IVD generic use consumablesDEVICES FOR SAMPLES ANALYSES (no laboratory generic products)Devices for samples analyses - various
Devices for samples analyses - other
EMDN code W05039099
Manufacturers registered in Europe (EUDAMED) 22
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 39
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 |
|---|---|---|---|
| Bio-Rad Present in Europe in other categories | United States | Liquichek Lyphochek | K121143 (2012) |
| Microgenics Corporation Present in Europe in other categories | United States | MAS DOA Total Liquid Assayed Drugs of Abuse Control MAS PAR TDM Liquid Assayed Therapeutic Drug Control CEDIA Speciality Control Set MAS Tox Control Liquid Assayed Toxicology Control MGC Select DAU Control Set MGC Clinical DAU Control Set | K103656 (2011) |
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | Syva® Emit® Calibrator/Control Level 5 Dimension® DOA-Positive Control Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 Syva® Emit® Calibrator/Control Level 2 Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 3 Syva® Emit® Calibrator/Control Level 0 (negative) | registered |
| LIN-ZHI INTERNATIONAL, INC. | United States | Multi-Analyte DAU Control Set C, Level 1 Control Multi-Analyte DAU Control Set E, Level 1 Control Multi-Analyte DAU Control Set A, Level 1 Control DAT Opiates Multi Control I Set Multi-Analyte DAU Control Set C, Level 2 Control Multi-Analyte DAU Control Set F, Level 2 Control | registered |
| Utak Laboratories, Inc. | United States | BARBITURATES 500 NG/ML Lead Level 2 TRICYCLICS LEVEL 2 V2 High Range AED II Mid Range AED II Lead Level 3 | K831736 (1983) |
| MEDTOX DIAGNOSTICS, INC. | United States | MEDTOX® PROFILE®-V MEDTOXScan® | registered |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | K982649 (1998) |
| Abbott Laboratories Present in Europe in other categories | United States | Alinity ARCHITECT | K873183 (1987) |
| IMMUNALYSIS CORP | – | Immunalysis | registered |
| CAROLINA LIQUID CHEMISTRIES CORPORATION | United States | CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT BL-425 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST325 CAROLINA LIQUID CHEMISTRIES CORP.® UDT SELECT CONTROL CLC18022 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425 CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST425 | registered |
| Randox Laboratories, Ltd. Present in Europe in other categories | United Kingdom | EDDP CONTROL 2 DRUG CONTROL - LEVEL 2 (TDM CONTROL 2) DOA CONTROL 2 THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) DRUG CONTROL - LEVEL 3 (TDM CONTROL 3) DRUG CONTROL - LEVEL 1 (TDM CONTROL 1) | K012319 (2001) |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | Vigil Synchron | K983709 (1998) |
| HORIBA INSTRUMENTS INCORPORATED | United States | Pointe Multi-Analyte E DAU Level 1 Control Pointe Multi-Analyte Set D Urine DAU Level 2 Control Pointe Multi-Analyte Set C Urine DAU Level 2 Control Pointe Multi-Analyte E DAU Level 2 Control Pointe Multi-Analyte Set D Urine DAU Level 1 Control Pointe Multi-Analyte Set C Urine DAU Level 1 Control | registered |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | Control Set DAT III Control Set DAT I Cfas DAT Qualitative Plus Clinical Control Set DAT II Control Set DAT Clinical | K080183 (2008) |
| Fertility Solutions, Inc. | United States | Fertility Solutions | K041240 (2004) |
| INFRARED LABORATORY SYSTEMS LLC | United States | Synermed® | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | K860919 (1986) |
| GERMAINE LABORATORIES, INC | United States | DOA NEGATIVE CONTROL DOA POSITIVE CONTROL | registered |
| HEMOSURE INC. | – | FIRST SIGN® | registered |
| QUIDEL CARDIOVASCULAR INC. Present in Europe in other categories | – | Triage | registered |
| STANBIO LABORATORY, L.P. | United States | TDM/B-Hydroxybutyrate Bi-Level Controls TDM/B-Hydroxybutyrate Tri-Level Controls | K813349 (1981) |
| TECHNO-PATH MANUFACTURING LIMITED Present in Europe in other categories | Ireland | Multichem WBT | K132174 (2013) |
| HAMILTON THORNE, INC. | United States | accu-beads® | registered |
| Instant Technologies, Inc. | – | Alere OratectCheck | registered |
| Bionostics, Inc. | United States | – | K063398 (2006) |
| CalibreScientific US, Inc. Present in Europe in other categories | United States | – | registered |
| Changchun Merydi Bio-Tech Co., Ltd. | China | – | registered |
| Changchun Wancheng Bio-Electron Co., Ltd. | China | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Elsohly Labs, Inc. | United States | – | K951817 (1995) |
| Jilin Hongyi Bio-Tech Co., Ltd. | China | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| SERO AS | Norway | – | registered |
| The Quality Assurance Service Corp. | United States | – | K812950 (1981) |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | K080085 (2008) |
| UTAK LABORATORIES, I | United States | – | registered |
| YENI BIYOTEKNOLOJI ANONIM SIRKETI | Türkiye | – | registered |
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