Identity
- Trade Name
- EMA (E29) Mouse Monoclonal Antibody FDA UDI
- Generic Name
- Epithelial membrane antigen (EMA) IVD, antibody FDA UDI
- Model / Reference
- 247M-97 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683130130 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
EMA (E29) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epithelial membrane antigen (EMA) IVD, antibody.
- IHC — Slmp, LLC · Class I
- FLEX Mono Mo A-Hu Epithelial Membrane Antigen Cl E29 RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · 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 [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
- Cell Marque Corporation
Sources (1)
- FDA UDI 59225004-8963-4134-98ae-515fe1d7bd77 33 fields · synced Jun 8, 2026