Identity
- Trade Name
- Mono Mo A-Hu MutL Protein Homolog 1 Cl ES05 FDA UDI
- Generic Name
- MLH1 antigen IVD, antibody FDA UDI
- Device Name
- Monoclonal Mouse Anti-Human MutL Protein Homolog 1 Clone ES05 FDA UDI
- Model / Reference
- M3640 FDA UDI
- Description
- Monoclonal Mouse Anti-Human MutL Protein Homolog 1 Clone ES05 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571105443 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- MLH1 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 — 1 Milliliter FDA UDI
Category: MLH1 antigen IVD, antibody
Mono Mo A-Hu MutL Protein Homolog 1 Cl ES05 by Agilent Technologies Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MLH-1 [BC23] — BIOCARE MEDICAL, LLC · Class I
- MLH-1 — BIOCARE MEDICAL, LLC · Class I
- MLH-1 — BIOCARE MEDICAL, LLC · Class I
- MLH-1 — 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
- Agilent Technologies Inc.
Sources (1)
- FDA UDI bfb3d0eb-894c-4ed3-a1e2-c39b58e11f64 36 fields · synced May 31, 2026