FLEX Mono Mo A-Hu CD246-ALK Protein, Cl OTI1A4, RTU (Dako Omnis)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- FLEX Monoclonal Mouse Anti-Human CD246 ALK Protein, Clone OTI1A4, Ready-to-Use (Dako Omnis) EUDAMEDFLEX Mono Mo A-Hu CD246-ALK Protein, Cl OTI1A4, RTU (Dako Omnis) FDA UDI
- Generic Name
- Anaplastic lymphoma kinase IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Mouse Anti-Human CD246 ALK Protein, Clone OTI1A4, Ready-to-Use (Dako Omnis) EUDAMEDFLEX Monoclonal Mouse Anti-Human CD246-ALK Protein, Clone OTI1A4, Ready-to-Use (Dako Omnis) FDA UDI
- Model / Reference
- GA785 EUDAMEDFDA UDIGA78561-2 EUDAMED
- Description
- FLEX Monoclonal Mouse Anti-Human CD246-ALK Protein, Clone OTI1A4, Ready-to-Use (Dako Omnis) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700573004560 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057R0301P3007C015701N9 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102030199 CANCER ANTIGENS - OTHER EUDAMED
- GMDN Term
- Anaplastic lymphoma kinase 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: Anaplastic lymphoma kinase IVD, antibody
FLEX Mono Mo A-Hu CD246-ALK Protein, Cl OTI1A4, RTU (Dako Omnis) by Agilent Technologies Singapore Pte Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID…
Similar devices
Also classified as Anaplastic lymphoma kinase IVD, antibody.
- VENTANA ALK D5F3 CDx Assay — Ventana Medical Systems · Class III
- ALK Protein (ALK-1) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Mouse Monoclonal Anti-Human ALK(MX064) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- ALK [5A4] — BIOCARE MEDICAL, LLC · Class I
- Rabbit Monoclonal Anti-Human ALK Antibody, EP302 — EPITOMICS, INC. · Class I
- ANTI- ALK — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human ALK Antibody, EP302 — EPITOMICS, INC. · Class I
- ALK Protein (ALK-1) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Agilent Technologies Singapore Pte Ltd
Sources (2)
- FDA UDI b8951e76-10da-4769-a86b-7be5a799dcb8 36 fields · synced Jun 19, 2026
- EUDAMED b17844eb-95ac-493d-bb3a-9cbcfc37b9ac 61 fields · synced Jun 19, 2026