FLEX Mono Rb a Hu PMS2, Cl EP51 RTU (Dako Omnis)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- FLEX Monoclonal Rabbit Anti-Human PMS2, Clone EP51 Ready-to-Use (Dako Omnis) EUDAMEDFLEX Mono Rb a Hu PMS2, Cl EP51 RTU (Dako Omnis) FDA UDI
- Generic Name
- Postmeiotic segregation increased 2 (PMS2) IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Rabbit Anti-Human PMS2, Clone EP51 Ready-to-Use (Dako Omnis) EUDAMEDFDA UDI
- Model / Reference
- GA087 EUDAMEDFDA UDIGA08761-2 EUDAMED
- Description
- FLEX Monoclonal Rabbit Anti-Human PMS2, Clone EP51 Ready-to-Use (Dako Omnis) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700573004508 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057R0301P3007C057901QD EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102030199 CANCER ANTIGENS - OTHER EUDAMED
- GMDN Term
- Postmeiotic segregation increased 2 (PMS2) 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Total Volume — 12 Milliliter FDA UDI
Category: Postmeiotic segregation increased 2 (PMS2) IVD, antibody
FLEX Mono Rb a Hu PMS2, Cl EP51 RTU (Dako Omnis) by Agilent Technologies Singapore Pte Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Postmeiotic segregation increased 2 (PMS2) IVD, antibody.
- IHC — Slmp, LLC · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class II
- Mono Rb A-Hu Postmeiotic Segregation Increased 2 Cl EP51 — Agilent Technologies Inc. · Class I
- FLEX Mono Rb A-Hu Postmeiotic Segregation Increased 2 Cl EP51 RTU (Link) — Agilent Technologies Inc. · Class I
- Tinto PMS2, MMab — BIO SB, INC. · Class I
- PMS2, MMab — BIO SB, INC. · Class I
- Tinto PMS2 (RBT-PMS2) — BIO SB, INC. · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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 d13d5d07-70c5-4302-ad89-5d5b2eed18a4 36 fields · synced Jul 9, 2026
- EUDAMED f443cf99-6738-4f7d-a8f8-0ec6331d43ba 61 fields · synced Jul 8, 2026