Identity
- Trade Name
- LAP 50 TEST KIT EUDAMEDRemel FDA UDI
- Generic Name
- Multiple Candida/yeast species culture isolate identification IVD, kit FDA UDI
- Device Name
- LAP TEST KIT EUDAMEDLAP Disk w/Reagent 50TST/KT FDA UDI
- Model / Reference
- R30168501 EUDAMEDFDA UDI
- Description
- LAP Disk w/Reagent 50TST/KT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848838028625 EUDAMEDFDA UDI
- Basic UDI-DI
- 8488380LAPDiskJR EUDAMED
- FDA Product Code
- JTO FDA UDI
- EMDN Code
- W0104080208 SINGLE TESTS (DISCS, STRIPS, DROPPERS...) EUDAMED
- GMDN Term
- Multiple Candida/yeast species culture isolate identification IVD, kit FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Lap 50 Test Kit by Remel, Inc. — Class A — 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 | 8488380LAPDiskJR | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Remel, Inc.
- EUDAMED SRN
- US-MF-000044686
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED ae9230ea-51d9-45f1-a6a9-39746f98e325 61 fields · synced Jul 10, 2026
- FDA UDI 14db375a-c725-4b3e-a51e-34373257a30a 34 fields · synced May 30, 2026