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FLEX Mono Rb A-Hu p40, Clone DAK-p40, RTU (Dako Omnis)
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref GA784Model GA78461-2
Identity
- Trade Name
- FLEX Monoclonal Rabbit Anti-Human p40, Clone DAK-p40, Ready-to-Use (Dako Omnis) EUDAMEDFLEX Mono Rb A-Hu p40, Clone DAK-p40, RTU (Dako Omnis) FDA UDI
- Generic Name
- p40 protein IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Rabbit Anti-Human p40, Clone DAK-p40, Ready-to-Use (Dako Omnis) EUDAMEDFDA UDI
- Model / Reference
- GA784 EUDAMEDFDA UDIGA78461-2 EUDAMED
- Description
- FLEX Monoclonal Rabbit Anti-Human p40, Clone DAK-p40, Ready-to-Use (Dako Omnis) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700573004553 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057R0301P3007C008601NE EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102030116 SQUAMOUS CELL CARCINOMA ANTIGEN EUDAMED
- GMDN Term
- p40 protein IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany 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: p40 protein IVD, antibody
FLEX Mono Rb A-Hu p40, Clone DAK-p40, RTU (Dako Omnis) by Agilent Technologies Singapore Pte Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as p40 protein IVD, antibody.
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- p40 (M) — BIOCARE MEDICAL, LLC · Class I
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- BOND — Leica Biosystems Newcastle, Limited · Class I
- p40 [BC28] BSA Free (1.0mg/ml) — BIOCARE MEDICAL, LLC · Class I
- p40 (P) — BIOCARE MEDICAL, LLC · Class I
- p40 (M) — BIOCARE MEDICAL, LLC · 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 e078b63b-a3f9-4e33-96ab-8974e1f020cd 36 fields · synced Jun 19, 2026
- EUDAMED 8b1cc3a8-5f16-418b-8527-219b3268776d 61 fields · synced Jun 19, 2026