Msh6

FDA UDI

Class I (US FDA UDI)

by Biocare Medical, Llc

Identity

Trade Name: MSH6 FDA UDI
Generic Name: MSH6 antigen IVD, antibody FDA UDI
Model / Reference: PM265H FDA UDI

Identifiers

Primary DI / UDI-DI: 00847627014115 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: MSH6 antigen 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

FDA UDI

Manufacturing Date

FDA UDI

Category: MSH6 antigen IVD, antibody

Msh6 by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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FLEX Mono Rb A-Hu MSH6, Cl EP49 RTU (Dako Omnis) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
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Rabbit Monoclonal Anti-Human MSH6 Antibody, EP49 — 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: Biocare Medical, Llc

Sources (1)

FDA UDI cc0ea935-c7bd-4743-8983-18c02119ead4 33 fields · synced May 30, 2026