Rabbit Monoclonal Anti-Human MART-1 Antibody, EP43

FDA UDI

Class I (US FDA UDI)

by Epitomics, Inc.

Identity

Trade Name: Rabbit Monoclonal Anti-Human MART-1 Antibody, EP43 FDA UDI
Generic Name: Melan-A/MART-1 peptide IVD, antibody FDA UDI
Device Name: Rabbit Monoclonal Anti-Human MART-1 (43), concentrated FDA UDI
Model / Reference: AC-0041BULK FDA UDI
Description: Rabbit Monoclonal Anti-Human MART-1 (43), concentrated FDA UDI

Identifiers

Primary DI / UDI-DI: 00810113061313 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: Melan-A/MART-1 peptide 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Melan-A/MART-1 peptide IVD, antibody

Rabbit Monoclonal Anti-Human MART-1 Antibody, EP43 by Epitomics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Melan-A/MART-1 peptide IVD, antibody.

MART-1 (M2-7C10) + Tyrosinase (T311) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
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 (M2-7C10) + Tyrosinase (T311) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
MART-1 Cocktail — 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

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Manufacturer

Manufacturer: Epitomics, Inc.

Sources (1)

FDA UDI 5d97a4b9-830d-4d1f-b97a-35ec5393c2c5 35 fields · synced Jun 8, 2026