Bond

FDA UDI

Class I (US FDA UDI)

by Leica Biosystems Newcastle, Limited

Identity

Trade Name: BOND FDA UDI
Generic Name: Melan-A/MART-1 peptide IVD, antibody FDA UDI
Device Name: Melan A (A103) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human melan A in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI
Model / Reference: PA0233-U FDA UDI
Description: Melan A (A103) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human melan A in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI

Identifiers

Catalog Number: PA0233-U FDA UDI
Primary DI / UDI-DI: 05055331334688 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

Yes

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

FDA UDI

Expiration Date

Yes

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Manufacturing Date

FDA UDI

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

Bond by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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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: Leica Biosystems Newcastle, Limited

Sources (1)

FDA UDI cc61aefe-b3bf-4f70-9ea8-c5b5a3f5fd17 36 fields · synced May 30, 2026