Identity
- Trade Name
- CD3 FDA UDI
- Generic Name
- CD3 cell marker IVD, antibody FDA UDI
- Model / Reference
- CME324C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627007704 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- CD3 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
Yes
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: CD3 cell marker IVD, antibody
Cd3 by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD3 cell marker IVD, antibody.
- CD3 (MRQ-39) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Mouse Monoclonal Anti-Human CD3(MX036) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- Human CD3 Pacific Blue™ Conjugate — LIFE TECHNOLOGIES LIMITED · Class I
- Novocastra — Leica Biosystems Newcastle, Limited · Class I
- ANTI-CD3 (T CELL) — Biogenex Laboratories, Inc. · Class I
- FLEX Poly Rb A-Hu CD3 RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Mouse Monoclonal Anti-Human CD3(MX036) Antibody — Fuzhou Maixin Biotech Co., Ltd. · 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 69d3bde1-dbe4-4a78-840b-3b203d00c98e 33 fields · synced Jun 8, 2026