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CEA NEXT GEN AccuLite CLIA Kit - 192 wells
EUDAMEDFDA UDIClass C (EU MDR)
Ref 4675-300BModel 4675-300
Identity
- Trade Name
- CEA NEXT GEN AccuLite CLIA Kit - 192 wells EUDAMEDMonobind AccuLite CEA Next Generation CLIA Kit - 192 Wells FDA UDI
- Generic Name
- Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Carcinoembryonic Antigen Next Generation (CEA-Next Generation) AccuLite® CLIA Test System EUDAMED
- Model / Reference
- 4675-300 EUDAMEDFDA UDI4675-300B EUDAMED
Identifiers
- Catalog Number
- 4675-300B FDA UDI
- Primary DI / UDI-DI
- 00816870022246 EUDAMEDFDA UDI
- Basic UDI-DI
- 081687002CEANG4675LL EUDAMED
- FDA Product Code
- DHX FDA UDI
- EMDN Code
- W0102030112 CARCINOEMBRYONIC ANTIGEN EUDAMED
- GMDN Term
- Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.6010 FDA UDI
- Market of Registration
- Netherlands 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
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 7.75 Inch FDA UDI
CEA NEXT GEN AccuLite CLIA Kit - 192 wells by Monobind, Inc. — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081687002CEANG4675LL | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Monobind Inc.
- EUDAMED SRN
- US-MF-000021611
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED f7347e7d-8fe5-4cc4-9126-9b52ef2a5f47 61 fields · synced Jun 19, 2026
- FDA UDI bdeab1b9-d74f-40ea-955f-69b5e343e906 36 fields · synced May 30, 2026