Identity
- Trade Name
- Anti-Jkb (JK2) FDA UDI
- Generic Name
- Anti-Jk^b red blood cell grouping IVD, antibody FDA UDI
- Device Name
- Blood Grouping Reagent, Anti-Jkb (Human/Murine Monoclonal) (P3.143) - This reagent is designed to determine the presence of the blood group antigen Jkb (JK2) on the surface of human red blood cells by manual tube method. FDA UDI
- Model / Reference
- 210535 FDA UDI
- Description
- Blood Grouping Reagent, Anti-Jkb (Human/Murine Monoclonal) (P3.143) - This reagent is designed to determine the presence of the blood group antigen Jkb (JK2) on the surface of human red blood cells by manual tube method. FDA UDI
Identifiers
- Catalog Number
- 210535 FDA UDI
- Primary DI / UDI-DI
- 23661562105353 FDA UDI
- GMDN Term
- Anti-Jk^b red blood cell grouping IVD, antibody FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anti-Jk^b red blood cell grouping IVD, antibody
Anti-Jkb (JK2) by Diagast — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anti-Jk^b red blood cell grouping IVD, antibody.
- ALBAclone Anti-Jkb (Monoclonal) — ALBA BIOSCIENCE LIMITED
- Anti-Jkb — IMMUCOR, INC.
- ORTHOTM Sera Anti-Jkb — ALBA BIOSCIENCE LIMITED
- ALBAclone Anti-Jkb (Monoclonal) — ALBA BIOSCIENCE LIMITED
- BIOCLONE — Ortho-Clinical Diagnostics
- Seraclone® Anti-Jkb (JK2) — Bio-Rad Medical Diagnostics GmbH
- Anti-Jkb (Monoclonal) Gamma-clone — IMMUCOR, INC.
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
- Diagast
Sources (1)
- FDA UDI 7f682e7d-5534-47c9-b2d3-7efba1687eec 35 fields · synced Jun 6, 2026