Identity
- Trade Name
- BOND™ FDA UDI
- Generic Name
- MLH1 antigen IVD, antibody FDA UDI
- Device Name
- MLH1 (Mismatch Repair Protein) (ES05) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human MutL homolog 1 (MLH1) protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX and BOND-III systems). The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. FDA UDI
- Model / Reference
- PA0988-X FDA UDI
- Description
- MLH1 (Mismatch Repair Protein) (ES05) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human MutL homolog 1 (MLH1) protein in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes BOND-MAX and BOND-III systems). The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. FDA UDI
Identifiers
- Catalog Number
- PA0988-X FDA UDI
- Primary DI / UDI-DI
- 05055331336729 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
Yes
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
Category: MLH1 antigen IVD, antibody
Bond™ by Leica Biosystems Newcastle, Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 37517da9-0d67-4470-953e-b7faa398deb4 36 fields · synced May 30, 2026