Identity
- Trade Name
- CD138 (EP201) Rabbit Monoclonal Primary Antibody FDA UDI
- Generic Name
- CD138 cell marker IVD, antibody FDA UDI
- Model / Reference
- 138R-28 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683124832 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
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: CD138 cell marker IVD, antibody
CD138 (EP201) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as CD138 cell marker IVD, antibody.
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- CD138 — BIOCARE MEDICAL, LLC · 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
- Cell Marque Corporation
Sources (1)
- FDA UDI abb67476-c41a-4e5b-a37f-b7649ff5db74 33 fields · synced Jun 1, 2026