Infectious diseasesControls/standards/calibrators - (infect. immunology/NAT)Controls - infect. immunology
Multiconstituent controls - inf.imm.
EMDN code W0105080807
Manufacturers registered in Europe (EUDAMED) 15
- 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) 19
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 | VIROTROL | 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 |
| 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 |
| 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 |
| HEMO BIOSCIENCE INC | United States | MQC C3 Control Cells MQC-CAT Hemo-QC | registered |
| American National Red Cross | – | DailyChek QC Kit Control Cells | registered |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | LeukoSure Fluorospheres LeukoSure Enumeration Kit | registered |
| DIAGAST Present in Europe in other categories | France | Beckman Coulter® PK® Systems Control Neg Control | registered |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | ORTHO | registered |
| Fujirebio Diagnostics,Inc. Present in Europe in other categories | United States | Beckman Coulter PK TP System Control Set | registered |
| MICRO TYPING SYSTEMS, INC | – | MTS | registered |
| Millipore Corp. Present in Europe in other categories | United States | ORTHO Daily QC Simulated Whole Blood Quality Control Kit | registered |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | Pro Advantage | registered |
| AMERICAN NATIONAL RED CROSS HEADQUARTERS | United States | – | registered |
| Bio-Rad Laboratories (Bio-Rad Services France) Present in Europe in other categories | France | – | registered |
| DiaMed GmbH (Bio-Rad Laboratories) Present in Europe in other categories | Switzerland | – | registered |
| MEDION GRIFOLS DIAGNOSTICS AG Present in Europe in other categories | Spain | – | registered |
| MilliporeSigma | United States | – | registered |
| QuidelOrtho Corporation | United States | – | registered |
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- Parent category : Controls - infect. immunology64 manufacturers