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FLEX Mono Mo A-Hu Epithelial Membrane Antigen Cl E29 RTU (Link)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- FLEX Mono Mo A-Hu Epithelial Membrane Antigen Cl E29 RTU (Link) FDA UDI
- Generic Name
- Epithelial membrane antigen (EMA) IVD, antibody FDA UDI
- Device Name
- FLEX Monoclonal Mouse Anti-Human Epithelial Membrane Antigen Clone E29 Ready-to-Use (Link) FDA UDI
- Model / Reference
- IR629 FDA UDI
- Description
- FLEX Monoclonal Mouse Anti-Human Epithelial Membrane Antigen Clone E29 Ready-to-Use (Link) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700572029106 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Epithelial membrane antigen (EMA) IVD, antibody FDA UDI
Classification
- Device Class
- Class I 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Epithelial membrane antigen (EMA) IVD, antibody
FLEX Mono Mo A-Hu Epithelial Membrane Antigen Cl E29 RTU (Link) by Agilent Technologies Singapore Pte Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Epithelial membrane antigen (EMA) IVD, antibody.
- IHC — Slmp, LLC · Class I
- EMA [Mc-5] — BIOCARE MEDICAL, LLC · Class I
- ANTI-EMA — Biogenex Laboratories, Inc. · Class I
- EMA [E29] — BIOCARE MEDICAL, LLC · Class I
- CONFIRM anti-EMA (E29) Mouse Monoclonal Primary Antibody — Ventana Medical Systems · Class I
- EMA (E29) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- EMA [Mc-5] — BIOCARE MEDICAL, LLC · Class I
- ANTI-EPITHELIAL MEMBRANE ANTIGEN — Biogenex Laboratories, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Singapore Pte Ltd
Sources (1)
- FDA UDI c793f7ee-b83d-4f59-94a5-a2f4fe4d12fb 36 fields · synced May 30, 2026