Identity
- Trade Name
- IH-Card Anti-C-E-K FDA UDI
- Generic Name
- Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination FDA UDI
- Device Name
- Blood Grouping Reagent; Gel card for use with the IH-system; Card for C (RH2), E (RH3) and K (KEL1) antigen typing; 228 cards of 6 microtubes FDA UDI
- Model / Reference
- 813272100 FDA UDI
- Description
- Blood Grouping Reagent; Gel card for use with the IH-system; Card for C (RH2), E (RH3) and K (KEL1) antigen typing; 228 cards of 6 microtubes FDA UDI
Identifiers
- Catalog Number
- 813272100 FDA UDI
- Primary DI / UDI-DI
- 07611969964789 FDA UDI
- GMDN Term
- Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination
IH-Card Anti-C-E-K by Bio-Rad Medical Diagnostics GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination.
- IH-Card Rh-Phenotype+K — Bio-Rad Medical Diagnostics GmbH
- Erytype S RhD Confirm — Bio-Rad Medical Diagnostics GmbH
- Erytype® S Rh Donor — Bio-Rad Medical Diagnostics GmbH
- IH-Card Rh-Phenotype+K — Bio-Rad Medical Diagnostics GmbH
- Erytype S Rh+K Type — Bio-Rad Medical Diagnostics GmbH
- Seraclone Anti-k (KEL2) — Bio-Rad Medical Diagnostics GmbH
- IH-Card Rh-Phenotype+K — Bio-Rad Medical Diagnostics GmbH
- IH-Card RhD(DVI-)+Phenotype — Bio-Rad Medical Diagnostics GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Bio-Rad Medical Diagnostics GmbH
Sources (1)
- FDA UDI 6d2ea13e-5afc-4379-857d-35eb561c766b 35 fields · synced May 29, 2026