Identity
- Trade Name
- BOND FDA UDI
- Generic Name
- MSH2 antigen IVD, antibody FDA UDI
- Device Name
- MSH2 (Mismatch Repair Protein) (79H11) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7ml. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). FDA UDI
- Model / Reference
- PA0989-U FDA UDI
- Description
- MSH2 (Mismatch Repair Protein) (79H11) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35 % ProClin™ 950 as a preservative and in a total volume of 7ml. The antibody is optimally diluted for use on the automated BOND-MAX or BOND-III instrument staining platforms in combination with BOND Polymer Refine Detection (DS9800). FDA UDI
Identifiers
- Catalog Number
- PA0989-U FDA UDI
- Primary DI / UDI-DI
- 05055331335920 FDA UDI
- 510(k) Number
- K213348 FDA UDI
- FDA Product Code
- PZJ FDA UDI
- GMDN Term
- MSH2 antigen IVD, antibody FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.1866 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: MSH2 antigen IVD, antibody
Bond by Leica Biosystems Newcastle, Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Mouse Monoclonal Anti-Human MSH2(MX061) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
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- MSH6 [BC19] — BIOCARE MEDICAL, LLC · Class I
Cleared under the same submission
K213348 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI 7eb18032-5e29-4381-9bda-c7a455a11967 37 fields · synced May 30, 2026