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CA 19-9 AccuLite CLIA Kit - 96 wells
EUDAMEDFDA UDIClass C (EU MDR)
Ref 3975-300AModel 3975-300
Identity
- Trade Name
- CA 19-9 AccuLite CLIA Kit - 96 wells EUDAMEDCA 19-9 AccuLite CLIA Test System - 96 Wells FDA UDI
- Generic Name
- Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Cancer Antigen 19-9 (CA 19-9) AccuLite® CLIA Test System EUDAMED
- Model / Reference
- 3975-300 EUDAMEDFDA UDI3975-300A EUDAMED
Identifiers
- Catalog Number
- 3975-300A FDA UDI
- Primary DI / UDI-DI
- 00816870022192 EUDAMEDFDA UDI
- Basic UDI-DI
- 081687002CA1993975VT EUDAMED
- FDA Product Code
- NIG FDA UDI
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 EUDAMED
- GMDN Term
- Cancer antigen 19-9 (CA19-9) 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
CA 19-9 AccuLite CLIA Kit - 96 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 | 081687002CA1993975VT | 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 5d95c694-330c-4f74-ac48-f69700fdd236 61 fields · synced Aug 1, 2026
- FDA UDI fe602d1f-656a-47e1-982e-ce6dd0f7fddb 36 fields · synced May 30, 2026