Identity
- Trade Name
- MSH2 IHC pharmDx (Dako Omnis) FDA UDI
- Generic Name
- MSH2 antigen IVD, antibody FDA UDI
- Device Name
- MSH2 IHC pharmDx (Dako Omnis) FDA UDI
- Model / Reference
- GE085 FDA UDI
- Description
- MSH2 IHC pharmDx (Dako Omnis) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700575005220 FDA UDI
- PMA Number
- P250004 FDA UDI
- FDA Product Code
- QNH FDA UDI
- GMDN Term
- MSH2 antigen IVD, antibody FDA UDI
Classification
- Device Class
- Class III 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
No
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 — 12 Milliliter FDA UDI
Category: MSH2 antigen IVD, antibody
MSH2 IHC pharmDx (Dako Omnis) by Agilent Technologies Inc. — Class III — 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
- ANTI-MSH2 — Biogenex Laboratories, 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
- BOND — Leica Biosystems Newcastle, Limited · Class II
Cleared under the same submission
P250004 also covers:
- MLH1 IHC pharmDx (Dako Omnis) — Agilent Technologies Inc.
- MMR Negative Control Reagent, Mouse (Dako Omnis) — Agilent Technologies Inc.
- MMR Negative Control Reagent, Rabbit (Dako Omnis) — Agilent Technologies Inc.
- MSH6 IHC pharmDx (Dako Omnis) — Agilent Technologies Inc.
- PMS2 IHC pharmDx (Dako Omnis) — Agilent Technologies Inc.
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
- Agilent Technologies Inc.
Sources (1)
- FDA UDI 2ec556eb-8a78-4fde-9367-e9755b528803 37 fields · synced May 30, 2026