Identity
- Trade Name
- CD20 [BC30] FDA UDI
- Generic Name
- CD20 cell marker IVD, antibody FDA UDI
- Model / Reference
- ALI3287G7 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627032126 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- CD20 cell marker IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CD20 cell marker IVD, antibody
A comprehensive medical device directory listing for the CD20 [BC30] immunohistochemistry reagent kit. This device is designed to detect and quantify CD20 cell marker in clinical specimens, making it a valuable tool for hematologists.
Similar devices
Also classified as CD20 cell marker IVD, antibody.
- CD20 (L26) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human CD20 C-term Antibody, EP7 — EPITOMICS, INC. · Class I
- Human CD20 PerCP Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Mono Mo A-Hu CD20/FITC Cl B-Ly1 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- CD20 (L26) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- CD20 (SP32) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- FLEX Mono Mo A-Hu CD20cy Cl L26 RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Human CD20 Pacific Orange™ Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (1)
- FDA UDI 718d7b2e-1bcb-4975-90a2-1e01fb729408 33 fields · synced Jul 29, 2026