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Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies FDA UDI
- Generic Name
- Mammaglobin IVD, antibody FDA UDI
- Device Name
- Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies FDA UDI
- Model / Reference
- 280C-14 FDA UDI
- Description
- Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683132561 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Mammaglobin 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: Mammaglobin IVD, antibody
Mammaglobin Cocktail (304-1A5 & 31A5) Mouse/Rabbit Monoclonal Antibodies by Cell Marque Corporation — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Mammaglobin IVD, antibody.
- Rabbit Monoclonal Anti-Human Mammaglobin Antibody, EP249 — EPITOMICS, INC. · Class I
- FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Link) — Agilent Technologies Inc. · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Rabbit Monoclonal Anti-Human Mammaglobin Antibody, EP249 — EPITOMICS, INC. · Class I
- FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Dako Omnis) — Agilent Technologies Inc. · Class I
- Rabbit Monoclonal Anti-Human Mammaglobin Antibody, EP249 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human Mammaglobin Antibody, EP249 — EPITOMICS, 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 24dcbb48-b7c5-4078-b56e-0d6fc2c3b3bb 34 fields · synced Jun 8, 2026