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VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody FDA UDI
- Generic Name
- Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent FDA UDI
- Device Name
- For use the MMR IHC Panel FDA UDI
- Model / Reference
- 790-5094 FDA UDI
- Description
- For use the MMR IHC Panel FDA UDI
Identifiers
- Catalog Number
- 07862261001 FDA UDI
- Primary DI / UDI-DI
- 07613336100592 FDA UDI
- 510(k) Number
- DEN170030 FDA UDI
- FDA Product Code
- QNH FDA UDIPZJ FDA UDI
- GMDN Term
- Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 864.1860 FDA UDI864.1866 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: Postmeiotic segregation increased 2 (PMS2) IVD, antibodyHereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
VENTANA Anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody by Ventana Medical Systems — Class III — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent.
- VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody — Ventana Medical Systems · Class II
- VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody — Ventana Medical Systems · Class III
- VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Primary Antibody — Ventana Medical Systems · Class III
- VENTANA Anti MSH6 (SP93) Rabbit Monoclonal Primary Antibody — Ventana Medical Systems · Class III
Cleared under the same submission
DEN170030 also covers:
- VENTANA ANTI-MLH1 (M1) Mouse Monoclonal Primary Antibody — Ventana Medical Systems
- VENTANA Anti MSH2 (G219-1129) Mouse Monoclonal Primary Antibody — Ventana Medical Systems
- VENTANA Anti MSH6 (SP93) Rabbit Monoclonal Primary Antibody — Ventana Medical Systems
- VENTANA Anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody — Ventana Medical Systems
P200019 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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ventana Medical Systems
Sources (1)
- FDA UDI afa222e8-08eb-405d-968b-14645549e953 35 fields · synced May 31, 2026