Identity
- Trade Name
- IHC FDA UDI
- Generic Name
- Carcinoembryonic antigen (CEA) IVD, antibody FDA UDI
- Device Name
- CEA(M), Clone Col-1, 10mL FDA UDI
- Model / Reference
- RTU CEA Carcinoembryonic Antigen (COL-1) Antibody (10ml) FDA UDI
- Description
- CEA(M), Clone Col-1, 10mL FDA UDI
Identifiers
- Catalog Number
- MM41-10 FDA UDI
- Primary DI / UDI-DI
- 00810170551062 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Carcinoembryonic antigen (CEA) 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carcinoembryonic antigen (CEA) IVD, antibody
Ihc by Slmp, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carcinoembryonic antigen (CEA) IVD, antibody.
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- CEA (M) — BIOCARE MEDICAL, LLC · Class I
- Mono Mo A-Hu Carcinoembryonic Antigen Cl II-7 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- CEA Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- Mono Mo A-Hu Carcinoembryonic Antigen Cl II-7 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- ANTI-CEA — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human CEA Antibody, EP216 — EPITOMICS, 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
- Slmp, LLC
Sources (1)
- FDA UDI aa9c8024-c34a-49b0-9f87-3f4702551ba4 34 fields · synced May 31, 2026