Identity
- Trade Name
- ABORhCard FDA UDI
- Generic Name
- ABO/Rh multiple blood grouping IVD, kit, agglutination FDA UDI
- Device Name
- Qualitative in vitro test that provides a simultaneous ABO and Rh determination of an individual's ABO and Rh status. Not for use in blood bank processing of blood products, for determining RHD status for the purpose of administering Rh immunoglobulin, or for screening purposes prior to transfusion. Single use device intended for individual blood group determination for educational and informational purposes. Each kit contains 25 tests. FDA UDI
- Model / Reference
- BT-101-025 FDA UDI
- Description
- Qualitative in vitro test that provides a simultaneous ABO and Rh determination of an individual's ABO and Rh status. Not for use in blood bank processing of blood products, for determining RHD status for the purpose of administering Rh immunoglobulin, or for screening purposes prior to transfusion. Single use device intended for individual blood group determination for educational and informational purposes. Each kit contains 25 tests. FDA UDI
Identifiers
- Catalog Number
- BT-101-025 FDA UDI
- Primary DI / UDI-DI
- 00815312020000 FDA UDI
- FDA Product Code
- OQX FDA UDI
- GMDN Term
- ABO/Rh multiple blood grouping IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9175 FDA UDI
- 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
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: ABO/Rh multiple blood grouping IVD, kit, agglutination
ABORhCard by Micronics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Micronics, Inc.
Sources (1)
- FDA UDI 72bfec55-35dd-4a06-abf9-e720c6e8f824 37 fields · synced May 30, 2026