ReagentsInfectious diseasesControls/standards/calibrators - (infect. immunology/NAT)
Controls - infect. immunology
EMDN code W01050808
Manufacturers registered in Europe (EUDAMED) 64
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 272
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS ORTHO | K063143 (2006) |
| EXACT DIAGNOSTICS, LLC | – | Exact Diagnostics | registered |
| THE BINDING SITE GROUP LIMITED Present in Europe in other categories | United States | Optilite® Hevylite® IgM Lambda Control Pack Freelite® Human Kappa Free Control Pack For use on the Roche Cobas™ c Systems Freelite® Human Lambda Free Control Pack for use on the Siemens BN™II IgD AMR Fluid Optilite® Alpha-1-Antitrypsin Control Pack Optilite® IgG1 Control Pack | K981914 (1999) |
| Zeptometrix Present in Europe in other categories | United States | NATtrol™ | K201403 (2022) |
| Immunodiagnostic Systems , Ltd. Present in Europe in other categories | United Kingdom | IDS-iSYS 25 VitDS Control Set IDS ACTH II Calibrator Set IDS-iSYS Intact PTH Calibration Verifiers IDS-iSYS Ostase® BAP Calibration Verifiers IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers IDS-iSYS Intact PTH Control Set | K161082 (2016) |
| MARDX DIAGNOSTICS, INC. | United States | Trinity Biotech | K951709 (1996) |
| Inova Diagnostics, Inc. Present in Europe in other categories | United States | NOVA Lite® IFA Hu (ANNA-1) Positive Control QUANTA Flash® β2GPI IgA Controls QUANTA Flash® DGP Screen Controls QUANTA Flash® LKM-1 Controls QUANTA Flash® Ro60 Controls QUANTA Flash RF IgM Controls | registered |
| CLARK LABORATORIES, INC. | United States | Trinity Biotech MarDx | K921573 (1992) |
| DIAGNOSTIC HYBRIDS, INC. | United States | Quidel Molecular Lyra D3 Solana Savanna | registered |
| OMNIS HEALTH, LLC | – | Embrace Gestational Diabetes Package - LARGE (9 vials) Embrace 50ct Test Strip Embrace Value Kit (50ct Included) Embrace Gestational Diabetes Package - SMALL (5 vials) Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) Embrace Pro Meter | registered |
| Chromsystems Instruments + Chemicals GmbH | Germany | Plasma Control Plasma Control Bi-Level Serum Control Urine Control Whole Blood Control Bi-Level Serum Control Bi-Level | registered |
| Nova Biomedical Corp. | United States | NOVA STATSTRIP STAT PROFILE STATSENSOR Nova Max | K041016 (2004) |
| TRIVIDIA HEALTH, INC. | United States | TRUE METRIX TRUEtrack TRUE FOCUS TRUEcontrol TRUENESS | registered |
| IMMUCOR, INC. Present in Europe in other categories | United States | Capture-R Ready Indicator Red Cells Monoclonal Control DAT Positive Control Cell Gamma-clone Control Checkcell (Weak) Checkcell | registered |
| CAROLINA LIQUID CHEMISTRIES CORPORATION | United States | CAROLINA LIQUID CHEMISTRIES CORP.® LP(a) RGT. KIT BL-204 CAROLINA LIQUID CHEMISTRIES CORP.® LP(a)-D RGT. KIT AU-204-D CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D RGT KIT Product No. ST500 CAROLINA LIQUID CHEMISTRIES CORP.® UCREA RGT. KIT BL-343 CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 2 CONTROL KIT PART# CC052 CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 3 CONTROL KIT PART# CC053 | registered |
| BIOTEST MEDICAL CORPORATION | – | Oracle Perfect 3 Smartest PersonaII B T M | registered |
| Eurotrol B.V. Present in Europe in other categories | Netherlands | Eurotrol GlucoTrol-NG Eurotrol AlbuTrol Eurotrol GlucoTrol-AQ GlucoLin CueSee VeriSTAT® CueSee® BGEM | K060215 (2006) |
| FORA CARE INC. Present in Europe in other categories | Taiwan | FORA | registered |
| Fort Worth Diagnostics, LLC | United States | Fort Worth Diagnostics | registered |
| ARKRAY USA, INC. Present in Europe in other categories | United States | Assure® Dose Normal (Level 1) Control Solution GLUCOCARD® 01 Control GLUCOCARD® Shine Level 1 Control Solution Assure® Dose Normal/High Control Solution Assure® Control - Control Solution Level 2 Assure® Control - Control Solution Level 2 & Level 3 | registered |
| BIOCHEMICAL DIAGNOSTICS INC Present in Europe in other categories | United States | Pregnancy-Skreen CENMED Adulter-Skreen iScreen | registered |
| HMD BIOMEDICAL INC. Present in Europe in other categories | – | PRECICHEK AutoCode foil packed test strip PRECICHEK AutoCode vial packed test strip PRECICHEK AC300 GL GoodLife AC11-Strip(foil) GL GoodLife AC-302 Blood Glucose Monitoring System(CORP.) | registered |
| Viramed Biotech AG Present in Europe in other categories | Germany | Borrelia B31 IgG ViraStripe® Deca Kit plus Borrelia All-In-One ViraChip Deca Kit Borrelia B31 IgG ViraStripe® Deca Kit Borrelia B31 IgM ViraStripe® Deca Kit plus Borrelia B31 ViraChip® IgM Test Kit Borrelia B31 IgM ViraStripe® Test Kit | K220016 (2022) |
| ACON Laboratories, Inc. | United States | Mission Plus Hemoglobin (Hb) Control Solution Kit On Call Plus Glucose Control Solution Kit On Call Express Voice Blood Glucose Monitoring System On Call Plus Blood Glucose Monitoring System On Call Vivid Pal Blood Glucose Monitoring System On Call Express Blood Glucose Monitoring System | K112653 (2012) |
| TOSOH CORPORATION Present in Europe in other categories | United States | AIA-PACK PA CALIBRATION VERIFICATION TEST SET AIA-PACK AFP Calibration Verification Test Set AIA-PACK PAP CALIBRATION VERIFICATION TEST SET AIA-PACK bHCG Calibration Verification Test Set AIA-PACK Homocysteine Control Set AIA-PACK BNP CONTROL SET | registered |
| Gold Standard Diagnostics Present in Europe in other categories | United States | Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | K203289 (2021) |
| Mmqci | – | Birlinn™ CoV2-Flu-RSV Control Panel M509 BioFire RP2.1/RP2.1plus Control Panel M441 FilmArray GI Control Panel M238 SPOTFIRE RSP Negative Control FilmArray Warrior Control Panel M290 SPOTFIRE RSP Pos & Neg Controls | registered |
| HOME AIDE DIAGNOSTICS, INC. | – | Easy Trak Control Solution - HIGH Easy Talk Control Solution - HIGH Easy Step Control Solution - HIGH Easy Plus II Control Solution - LOW Easy Plus II Control Solution - HIGH Easy Step Control Solution - LOW | registered |
| PHILOSYS Co., Ltd | United States | GlucoTrack Solution Level 2 GlucoTrack Solution Level 1 Gmate® Control Solution Level 2 Gmate® Control Solution Level 3 Pip Control Solution Low GlucoTrack Solution Level 3 | registered |
| WAL-MART STORES, INC. | – | ReliOn Ultima ReliOn™ Premier Control Solution Level 1 ReliOn™ Premier Control Solution Level 2 ReliOn™ Premier Voice Basic Meter ReliOn™ Premier Classic Meter ReliOn™ Confirm/Micro Control | registered |
| BIONIME CORPORATION Present in Europe in other categories | United States | GE Rightest RIGHTEST GT333 Control Solution | K133003 (2013) |
| FUJIFILM WAKO PURE CHEMICAL CORPORATION Present in Europe in other categories | Japan | Autokit Micro Albumin Control Set Autokit Micro Albumin Calibrator Set Complement Control uTASWako DCP Control L uTASWako AFP-L3 Control L uTASWako DCP Control H | registered |
| MONOBIND, INC. Present in Europe in other categories | United States | Rubella IgG AccuBind ELISA Test System - 192 Wells Rubella IgM AccuBind ELISA Test System - 96 Wells Rubella IgG AccuBind ELISA Test System - 96 Wells Rubella IgM AccuBind ELISA Test System - 192 Wells Toxo IgM AccuBind ELISA Test System - 192 Wells Toxo IgG AccuBind ELISA Test System - 192 Wells | registered |
| QUIDEL CARDIOVASCULAR INC. Present in Europe in other categories | – | Triage | registered |
| Quantimetrix Corp. | United States | Ammonia Alcohol Control Level 3 Set 3x5mL Dropper Spinal Fluid Control Level 2 Set 3x3mL Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL Ammonia Alcohol Control Level 1 Set 3x5mL Dropper Spinal Fluid Control Level 1&2 Set 2x3mL Ammonia Alcohol Control Level 2 Set 3x5mL | K152117 (2016) |
| Quest Intl., Inc. | United States | ReQuest SeraQuest | K982281 (1998) |
| Sebia Present in Europe in other categories | United States | NORMAL CDT CONTROL (5 ) MINICAP Hb A1c CAPI 3 Hb A1c isatuximab CONTROL CAPILLARYS Hb A1c HIGH CDT CONTROL | registered |
| U. S. Diagnostics, Inc. | United States | INFINITY™ Normal Control Solution INFINITY™ Low Control Solution EasyGluco™ Low Control Solution EasyGluco™ Normal Control Solution EasyGluco™ High Control Solution EasyGluco™G2 Starter Kit | registered |
| ALBA BIOSCIENCE LIMITED Present in Europe in other categories | United Kingdom | ALBAcyte IgG Sensitized Red Blood Cells ALBAcyte C3 Coated Red Blood Cells ALBAcheck - BGS Monoclonal Control ALBAsure QC Kit Ortho™ Confidence Manual System AlbaQ-Chek® | registered |
| Diagnostic Automation, Inc. | – | AccuDiag ™ QMedix™ | registered |
| GERMAINE LABORATORIES, INC | United States | AimStrip Tandem Lipid Profile and glucose measuring system KETONE SERUM CONTROLS AimStrip Tandem Total Cholesterol Control Solution AimStrip Tandem Total Triglycerides Control Solution AIMSTRIP PLUS, GLUCOSE CONTROL SOLUTION AIMSTRIP HEMOGLOBIN OPTICAL VERIFIERS | registered |
| OSANG HEALTHCARE Co., Ltd. Present in Europe in other categories | South Korea | Oh’Care Lite Blood Glucose Monitoring System Kit Oh'Care Lite Smart Glucose control solution-Level 3 Oh'Care Lite Smart Glucose control solution-Level 1 Oh'Care Lite Smart Glucose control solution-Level 2 Element™Plus Meter Element™ Meter | registered |
| Roche Diagnostics Operations Inc. | United States | EXACTA GLANCE ACCU-CHEK SMART VIEW ACCU-CHEK INFORM II ACCU-CHEK GUIDE ACCU-CHEK Aviva | registered |
| SENTINEL CH. SPA Present in Europe in other categories | Italy | ACE Control Lipase NG OC CTRL 2 Lipase NG OC CTRL 1 Lp(a) Control Set ACE Control Set Cystatin C Controls | registered |
| B.R.A.H.M.S GmbH Present in Europe in other categories | Germany | B.R.A.H.M.S CgA II KRYPTOR QC B.R.A.H.M.S PlGF plus KRYPTOR QC B.R.A.H.M.S PCT sensitive KRYPTOR QC B.R.A.H.M.S sFlt-1 KRYPTOR LIN B.R.A.H.M.S sFlt-1 KRYPTOR QC B.R.A.H.M.S PlGF plus KRYPTOR LIN | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | BD Veritor System Group A Strep Control Swab set BD Veritor™ System RSV Control Swab Set BD Veritor SARS-CoV-2 Control Swab Set BD Veritor™ System Flu A+B Control Swab Set BD Respiratory Viral Panel for BD MAX™ System BD Respiratory Viral Panel-SCV2 for BD MAX™ System | registered |
| Biofire Defense, LLC | United States | BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel BioFire® Global Fever Special Pathogens Panel BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane BioFire Warrior Panel Control Kit BioFire® COVID-19 Test 2 | K261475 (2026) |
| Canterbury Scientific , Ltd. Present in Europe in other categories | New Zealand | ExtendSURE TOSOH | K071648 (2007) |
| Diagenode Present in Europe in other categories | Belgium | Mycoplasma genitalium macrolide resistance IVT A2058T Controls Mycoplasma genitalium macrolide resistance IVT A2059C Control Mycoplama genitalium IVT Wild type control Mycoplasma genitalium macrolide resistance IVT A2058G Control Mycoplasma genitalium Macrolide Resistance IVT A2058C Control Mycoplasma genitamium macrolide resistance IVT A 2059G control | registered |
| Diamedix Corp. | United States | Diamedix | K093101 (2011) |
| Diazyme Laboratories Present in Europe in other categories | United States | Diazyme | K092911 (2010) |
| IMMCO DIAGNOSTICS, INC. | United States | Immco Diagnostics, Inc. | registered |
| Instrumentation Laboratory CO Present in Europe in other categories | United States | HemosIL AcuStar Anti-Cardiolipin IgM Controls HemosIL Homocysteine Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls HemosIL AcuStar Anti-B2GPI Domain 1 Controls HemosIL AcuStar Anti-Cardiolipin IgG Controls HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls | registered |
| Kamiya Biomedical Co. Present in Europe in other categories | United States | K-ASSAY® Cystatin C Control K-ASSAY® hsCRP Control K-ASSAY® Insulin Control K-ASSAY® Beta-2 Microglobulin Urine Control K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma Control | registered |
| Prodigy Diabetes Care, LLC | – | Prodigy Voice Blood Glucose Monitoring System Prodigy Control Solution Low Prodigy AutoCode Blood Glucose Monitoring System Prodigy Control Solution High | registered |
| REVVITY DISCOVERY LIMITED | – | Mimix™ Myeloid Cancer Panel gDNA Reference Standard Mimix™ Geni™ Negative FFPE Reference Standard Mimix™ OncoSpan gDNA Reference Standard Mimix™ OncoSpan FFPE Reference Standard Mimix™ Quantitative Multiplex FFPE reference standard Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference Standard | registered |
| Roche Molecular Systems, Inc. | United States | cobas® 4800 System Lysis Kit cobas® 4800 Systems Internal Control Kit cobas® SARS-CoV-2 Qualitative 192T cobas® SARS-CoV-2 Qualitative Control Kit cobas® SARS-CoV-2 Qualitative 480T | K240867 (2025) |
| Streck Laboratories, Inc. Present in Europe in other categories | United States | A1c-Cellular A1c-Cellular Linearity MDx-Chex for BC-GN MDx-Chex for BCID2 MDx-Chex for BC-GP | K260041 (2026) |
| AgaMatrix, Inc. | United States | AgaMatrix | registered |
| Bio-Rad Medical Diagnostics GmbH Present in Europe in other categories | – | Seraclone Control AB0+Rh IH-Card Control Coombscell-E IH-Internal QC IH-Basic QC | registered |
| HORIBA INSTRUMENTS INCORPORATED | United States | Pointe Lipoprotein (a) Control Set Pointe Scientific, Inc. Toxoplasma IgG Pointe Scientific, Inc. Toxoplasma IgM Pointe Scientific, Inc. Rubella IgM Pointe Scientific, Inc. Rubella IgG | registered |
| KPI HEALTHCARE, INC. | – | CURO Glucose Strips Curo L5 CURO L5 Total Cholesterol Strips CURO G6 Glucose Meter | registered |
| MHC MEDICAL PRODUCTS, LLC | – | EasyTouch Kroger Healthpro HealthPro BluLink | registered |
| Medica Corp. | United States | CRP Quality Control Kit Level 3 HbA1c Quality Control Kit Level 1 HbA1c Quality Control Kit Level 2 CRP Quality Control Kit Level 2 CRP Quality Control Kit Level 1 | registered |
| Medtest Dx, Inc. | – | MedTest DX Elevated HCG Control Vial Label - B MedTest DX HCG Control Set Level B MedTest DX HCG Control Set Level A MedTest DX Elevated HCG Control Vial Label - A MedTest DX HCG Control Set | registered |
| Mio Labs Inc. | – | Health Wealth Safe TeleMate Health &TeleRPM MIO Brilliant Care TeleRPM & Chronica | registered |
| QUALIGEN INC. Present in Europe in other categories | United States | FastPack® IP SHBG Method Verification Kit - PSA Method Verification Kit - Vitamin D Control Kit - PSA | K062957 (2007) |
| Quidel Corp. | United States | QuickVue InflammaDry Sofia | K230349 (2023) |
| ARLINGTON SCIENTIFIC, INC. | United States | ASI Rubella IgG EIA Test ASI Rubella IgM EIA Test ASI Toxoplasma IgG EIA Test ASI Toxoplasma IgM EIA Test | registered |
| ASTORIA-PACIFIC, INC. | United States | SPOTCHECK | registered |
| Ascensia Diabetes Care Holdings AG Present in Europe in other categories | United States | CONTOUR® NEXT | registered |
| Awareness Technology, Inc. | United States | DriDye 405 DriDye 405/ 450 DriDye 450 DriDye 492 | K892656 (1989) |
| Cliniqa Corporation | United States | DIABETES CNTL, Bi-L Hemoglobin A1c Calibrators Fructosamine Calibrator DIABETES CNTL, Smpl, 1x2x0.5mL | K121237 (2012) |
| DRG Instruments Gesellschaft mit beschränkter Haftung | – | Crosslaps Serum ELISA Borrelia burgdorferi IgG (Lyme) ELISA B. burgdorferi IgG/IgM ELISA Borrelia burgdorferi IgM (Lyme) ELISA | registered |
| DRG International Inc | United States | Crosslaps Serum ELISA B. burgdorferi IgG/IgM ELISA Borrelia burgdorferi IgG (Lyme) ELISA Borrelia burgdorferi IgM (Lyme) ELISA | registered |
| DiaSys Diagnostic Systems GmbH | Germany | TruCal Procalcitonin Calibrator Set TruLab Procalcitonin Bi-Level Controls β-Hydroxybutyrate 21 Tri-Level Controls β-Hydroxybutyrate 21 Bi-Level Controls | registered |
| Fujirebio Diagnostics,Inc. Present in Europe in other categories | United States | Vitamin D Control Syphilis Control Beckman Coulter PK TP System Control Set | K133197 (2014) |
| HEMO BIOSCIENCE INC | United States | MQC C3 Control Cells MQC-CAT Hemo-QC | registered |
| HORIBA ABX SAS Present in Europe in other categories | France | Yumizen C1200 C02 Control ABX PENTRA CO2 CONTROL Yumizen C1200 L1 Cystatin C Control Yumizen C1200 L2 Cystatin C Control | registered |
| Helena Laboratories | United States | Alkaline Phosphatase Isoenzyme Control (1 x 1 mL) Gel Alk Phosphatase Isoenzyme Control (1 x 2 mL) REP Cholesterol Profile Control (5 x 1 mL) A1AT Controls | K974609 (1998) |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| Phadia AB Present in Europe in other categories | Sweden | Quality Club Specific IgE Quality Club EliA Autoimmunity Quality Club Total IgE Quality Club ECP | registered |
| STANBIO LABORATORY, L.P. | United States | Blood Glucose Control Solution B-Ketone Control Solution Direct (HDL/LDL) Cholesterol Calibrator Ketone Serum Controls | registered |
| ABOUND Diagnostics, Inc. | – | VivaGuard Ino Control Solution VivaGuard Ino Smart Blood Glucose Meter VivaGuard Ino Blood Glucose Meter | registered |
| AMITY HOLDINGS, LLC Present in Europe in other categories | – | Pip | registered |
| Able Diagnostics Inc | – | VivaGuard Ino | registered |
| All Medicus Co.,Ltd. | South Korea | Embrace Pro Blood Glucose Test Strip Embrace Pro Blood Glucose Test Meter Embrace Pro Control Solution | registered |
| Bion Enterprises, Ltd. | United States | Borrelia IgM Control Borrelia IgG Control Borrelia Negative Control | registered |
| GENMARK DIAGNOSTICS, INC. Present in Europe in other categories | United States | ePlex System | registered |
| HUDSON SCIENTIFIC, LLC | United States | D-Care | registered |
| IBL International GmbH Present in Europe in other categories | – | Testosterone Luminescence Immunoassay Unassayed Testosterone QC Material | registered |
| Ideal Life Inc | United States | IDEAL LIFE Blood Glucose Test Strips 1 vial of 25 Test Strips IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips) IDEAL LIFE Control Solution Level II | registered |
| LIVONGO HEALTH, INC | – | Livongo Welcome Kit Livongo Livongo Control Solution | registered |
| Life Technologies Corporation | United States | Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay Kit Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control | K233453 (2024) |
| Lifescan, Inc. Present in Europe in other categories | United States | OneTouch Verio Control Solution OneTouch Ultra | K971014 (1997) |
| Luminex Corporation Present in Europe in other categories | United States | Respiratory Pathogens Flex (RP Flex) Extraction Tray Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge Respiratory Pathogens Flex (RP Flex) Amplification Tray | registered |
| MEDSOURCE INTERNATIONAL LLC | – | MedSource Glucometer Test Solution (Normal, high) MedSource Glucose Meter, DS-A MedSource Glucometer Test Strips, DS-A | registered |
| TCOAG IRELAND LIMITED Present in Europe in other categories | Ireland | TriniCHECK Level 1 TriniCHECK Level 3 TriniCHECK Level 2 | registered |
| Teladoc Health, Inc. | United States | Teladoc Health, Inc. | registered |
| Abionic SA Present in Europe in other categories | Switzerland | abioSCOPE Control IVD CAPSULE Control PSP | registered |
The 100 most active manufacturers are shown, out of 272.
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