Identity
- Trade Name
- ANTI-CD138 FDA UDI
- Generic Name
- CD138 cell marker IVD, antibody FDA UDI
- Model / Reference
- NU837-UC FDA UDI
Identifiers
- Catalog Number
- NU837-UC FDA UDI
- Primary DI / UDI-DI
- 00810119675101 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
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: CD138 cell marker IVD, antibody
Anti-Cd138 by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CD138 cell marker IVD, antibody.
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Rabbit Monoclonal Anti-Human CD138 Antibody, EP201 — EPITOMICS, INC. · Class I
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- 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 — BIOCARE MEDICAL, LLC · 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
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI cb597324-5bbd-494c-ab73-f3f8b2a0ba96 36 fields · synced May 31, 2026