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Free PSA AccuLite CLIA Kit - 96 wells
EUDAMEDFDA UDIClass C (EU MDR)
Ref 2375-300AModel 2375-300
Identity
- Trade Name
- Free PSA AccuLite CLIA Kit - 96 wells EUDAMEDFree PSA AccuLite CLIA Test System - 96 Wells FDA UDI
- Generic Name
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Free Prostate Specific Antigen (fPSA) AccuLite® CLIA Test System EUDAMED
- Model / Reference
- 2375-300 EUDAMEDFDA UDI2375-300A EUDAMED
Identifiers
- Catalog Number
- 2375-300A FDA UDI
- Primary DI / UDI-DI
- 00816870022277 EUDAMEDFDA UDI
- Basic UDI-DI
- 081687002FPSA2375J8 EUDAMED
- FDA Product Code
- LTJ FDA UDI
- EMDN Code
- W0102030114 FREE PROSTATIC SPECIFIC ANTIGEN EUDAMED
- GMDN Term
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.6010 FDA UDI
- 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
Free PSA 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 | 081687002FPSA2375J8 | 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 1fc24273-3751-4d80-9566-0a687e330777 61 fields · synced Sep 17, 2026
- FDA UDI 98901413-ef1f-4a35-a634-b568dd999bfa 36 fields · synced May 29, 2026