MSH2 MMab

FDA UDI

Class I (US FDA UDI)

by Bio Sb, Inc.

Identity

Trade Name: MSH2 MMab FDA UDI
Generic Name: MSH2 antigen IVD, antibody FDA UDI
Device Name: Anti-MSH2 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI
Model / Reference: Concentrate, 1 ml FDA UDI
Description: Anti-MSH2 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 FDA UDI

Identifiers

Catalog Number: BSB 5776 FDA UDI
Primary DI / UDI-DI: B502BSB57760 FDA UDI
FDA Product Code: NJT FDA UDI
GMDN Term: MSH2 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

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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

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Serial Number

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Expiration Date

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Manufacturing Date

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MRI Safety

MR Safe FDA UDI

Category: MSH2 antigen IVD, antibody

MSH2 MMab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MSH2 antigen IVD, antibody.

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BOND™ — Leica Biosystems Newcastle, Limited · Class I
Mouse Monoclonal Anti-Human MSH2(MX061) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
Mono Mo A-Hu MutS Protein Homolog 2 Cl FE11 — Agilent Technologies Inc. · Class I
BOND — Leica Biosystems Newcastle, Limited · Class II
MSH6 [BC19] — 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: Bio Sb, Inc.

Sources (1)

FDA UDI 9715b644-d98b-4fd2-beca-a44376f9a395 34 fields · synced May 31, 2026