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FLEX Mono Mo A-Hu MSH2, Cl FE11 RTU (Dako Omnis)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref GA085Model GA08561-2
Identity
- Trade Name
- FLEX Monoclonal Mouse Anti-Human MSH2, Clone FE11 Ready-to-Use (Dako Omnis) EUDAMEDFLEX Mono Mo A-Hu MSH2, Cl FE11 RTU (Dako Omnis) FDA UDI
- Generic Name
- MSH2 antigen IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Mouse Anti-Human MSH2, Clone FE11 Ready-to-Use (Dako Omnis) EUDAMEDFDA UDI
- Model / Reference
- GA085 EUDAMEDFDA UDIGA08561-2 EUDAMED
- Description
- FLEX Monoclonal Mouse Anti-Human MSH2, Clone FE11 Ready-to-Use (Dako Omnis) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700573004485 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057R0301P3007C057701Q3 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102030199 CANCER ANTIGENS - OTHER EUDAMED
- GMDN Term
- MSH2 antigen IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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 — 12 Milliliter FDA UDI
Category: MSH2 antigen IVD, antibody
FLEX Mono Mo A-Hu MSH2, Cl FE11 RTU (Dako Omnis) by Agilent Technologies Singapore Pte Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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
- Mono Mo A-Hu MutS Protein Homolog 2 Cl FE11 — Agilent Technologies Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Singapore Pte Ltd
Sources (2)
- FDA UDI 8917aa9f-45bf-463c-8be4-55096cda9c0f 36 fields · synced Jul 14, 2026
- EUDAMED f255ce93-f4b3-459a-9590-b223d1a6484a 61 fields · synced Jul 14, 2026