Identity
- Trade Name
- ANTI-MSH2 FDA UDI
- Generic Name
- MSH2 antigen IVD, antibody FDA UDI
- Model / Reference
- AN743-5M FDA UDI
Identifiers
- Catalog Number
- AN743-5M FDA UDI
- Primary DI / UDI-DI
- 00810119671646 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Category: MSH2 antigen IVD, antibody
Anti-Msh2 by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MSH2 antigen IVD, antibody.
- MSH2 — BIOCARE MEDICAL, LLC · Class I
- Tinto MSH2, MMab — BIO SB, INC. · Class I
- Tinto MSH2 MMab — BIO SB, INC. · Class I
- IHC — Slmp, LLC · Class I
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI 9689750f-f142-4a14-9a96-bd3f2687eb73 35 fields · synced Jun 1, 2026