Identity
- Trade Name
- Anti-Jkb FDA UDI
- Generic Name
- Anti-Jk^b red blood cell grouping IVD, antibody FDA UDI
- Device Name
- This reagent is used for the detection of the Jkb antigen on red blood cells by tube test. This product configuration is a single vial. FDA UDI
- Model / Reference
- 0007604 FDA UDI
- Description
- This reagent is used for the detection of the Jkb antigen on red blood cells by tube test. This product configuration is a single vial. FDA UDI
Identifiers
- Catalog Number
- 0007604 FDA UDI
- Primary DI / UDI-DI
- 10888234000822 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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: Anti-Jk^b red blood cell grouping IVD, antibody
Anti-Jkb by Immucor, Inc. — 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
- 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 (JK2) — DIAGAST
- 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
- Immucor, Inc.
Sources (1)
- FDA UDI 1ea93f32-6885-4d9a-8325-e00f59563a6e 35 fields · synced May 31, 2026