Identity
- Trade Name
- CD138 FDA UDI
- Generic Name
- CD138 cell marker IVD, antibody FDA UDI
- Model / Reference
- CM167CK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627006677 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- CD138 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
Yes
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: CD138 cell marker IVD, antibody
Cd138 by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD138 cell marker IVD, antibody.
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- FLEX Mono Mo A-Hu CD138 Cl MI15 RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- CD138-PE — CYTOGNOS SL · Class I
- CD138 (EP201) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Mono Mo A-Hu CD138/APC Cl MI15 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- CD138 (RBT-CD138) — BIO SB, 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 06162ed0-a6b0-4a16-b39d-d9e261a5e9e6 33 fields · synced May 30, 2026