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Mammaglobin (31A5) Rabbit Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 280R-17Model 280R-1X seriesRef 280R-10Ref 280R-14Ref 280R-18
Identity
- Trade Name
- Mammaglobin (31A5) Rabbit Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Mammaglobin IVD, antibody FDA UDI
- Device Name
- Mammaglobin (31A5) Rabbit Monoclonal Antibody EUDAMED
- Model / Reference
- 280R-18 EUDAMEDFDA UDI280R-14 EUDAMEDFDA UDI280R-10 EUDAMEDFDA UDI280R-17 EUDAMEDFDA UDI280R-1X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683132745 EUDAMEDFDA UDI00841683132660 EUDAMEDFDA UDI00841683107217 EUDAMEDFDA UDI00841683132721 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831280R-1DL EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Mammaglobin IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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 (31A5) Rabbit Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (8)
- FDA UDI 4ff07a08-a4c1-4335-821f-269c97e773f6 33 fields · synced Jul 30, 2026
- FDA UDI 0bbebced-009f-4195-b357-a2403c8d8518 33 fields · synced May 30, 2026
- FDA UDI 0ba9d30e-4770-4d2a-9abb-4f865028abd5 33 fields · synced May 30, 2026
- FDA UDI 752111dc-05b2-430c-9550-a78ed1dbd07f 33 fields · synced May 30, 2026
- EUDAMED 26b06171-db52-49f9-9bc2-49b3d89fc01d 61 fields · synced Jul 10, 2026
- EUDAMED 416f3934-6297-4a07-8ad4-9dc8b489bf8b 61 fields · synced Jul 20, 2026
- EUDAMED a450411f-4b5a-4bdc-875c-92e9e0909a05 61 fields · synced Jul 29, 2026
- EUDAMED f733467d-fe5b-4bcb-be12-1e49451596de 61 fields · synced Jul 30, 2026