Identity
- Trade Name
- CA-9 FDA UDI
- Generic Name
- Carbonic anhydrase IVD, antibody FDA UDI
- Model / Reference
- ACI3285A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627031433 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Carbonic anhydrase 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: Carbonic anhydrase IVD, antibody
Ca-9 by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbonic anhydrase IVD, antibody.
- Carbonic Anhydrase IX (CA IX) (MRQ-54) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human Carbonic Anhydrase 9 Antibody, EP161 — EPITOMICS, INC. · Class I
- Carbonic Anhydrase IX (CA IX) (EP161) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Carbonic Anhydrase IX (CA IX)(MRQ-54) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Carbonic Anhydrase IX (CA IX)(EP161) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human Carbonic Anhydrase 9 Antibody, EP161 — EPITOMICS, INC. · Class I
- Carbonic Anhydrase IX (CA IX)(MRQ-54) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Anti-CA-IX — Biogenex Laboratories, Inc. · 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 |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (1)
- FDA UDI 0d04db35-5e38-4252-95a1-712a4d87603f 33 fields · synced May 30, 2026