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MART-1 (Melan A) (A103) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 281M-88Model 281M-8X seriesRef 281M-86Ref 281M-84
Identity
- Trade Name
- MART-1 (Melan A) (A103) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Melan-A/MART-1 peptide IVD, antibody FDA UDI
- Device Name
- MART-1 (Melan A) (A103) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 281M-84 EUDAMEDFDA UDI281M-88 EUDAMEDFDA UDI281M-86 EUDAMEDFDA UDI281M-8X series EUDAMED281M-87 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683132820 EUDAMEDFDA UDI00841683132868 EUDAMEDFDA UDI00841683132844 EUDAMEDFDA UDI00841683132851 FDA UDI
- Basic UDI-DI
- 008416831281M-8DG EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Melan-A/MART-1 peptide 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: Melan-A/MART-1 peptide IVD, antibody
MART-1 (Melan A) (A103) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Melan-A/MART-1 peptide IVD, antibody.
- Mouse Monoclonal Anti-Human MART-1/MelanA(MX118) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Melan A — BIOCARE MEDICAL, LLC · Class I
- MART-1 Cocktail — BIOCARE MEDICAL, LLC · Class I
- ANTI-MELAN-A — Biogenex Laboratories, Inc. · Class I
- Mouse Monoclonal Anti-Human MART-1/MelanA(MX118) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- MART-1 Cocktail — BIOCARE MEDICAL, LLC · Class I
- Melan A (M) — BIOCARE MEDICAL, LLC · Class I
- FLEX Mono Mo A-Hu Melan-A Cl A103 RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · 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 (7)
- FDA UDI f66d11e6-de46-49d3-9c4b-9e493a36e4b4 33 fields · synced Aug 2, 2026
- FDA UDI 4f38ead5-4a0e-4997-b8e8-e0734fa09bf5 33 fields · synced May 29, 2026
- FDA UDI f6bd4023-0589-4e62-9add-3911a75b1ff8 33 fields · synced May 30, 2026
- FDA UDI 7309b5a4-9ff7-415a-bf05-0e7bd18504b7 33 fields · synced May 30, 2026
- EUDAMED a9a8a4d3-19df-4aac-9729-67868f8b412b 61 fields · synced Jun 20, 2026
- EUDAMED 536dffa0-a72a-4ff0-9d1b-aee47d6e8eed 61 fields · synced Jul 26, 2026
- EUDAMED 0a1f6c08-8897-4b28-a65d-1c970fb6537f 61 fields · synced Aug 2, 2026