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ADAM-rWBC Kit
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref AD1K-050Model ADAM-rWBC Kit
Identity
- Trade Name
- ADAM-rWBC Kit EUDAMEDFDA UDI
- Generic Name
- White blood cell count IVD, reagent FDA UDI
- Device Name
- AD1K-050 EUDAMEDIt is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC. FDA UDI
- Model / Reference
- ADAM-rWBC Kit EUDAMEDAD1K-050 EUDAMEDFDA UDI
- Description
- It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC. FDA UDI
Identifiers
- Catalog Number
- AD1K-050 FDA UDI
- Primary DI / UDI-DI
- 08809317540269 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809317540269 EUDAMED
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W0103010199 REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER EUDAMED
- GMDN Term
- White blood cell count IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- Italy 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ADAM-rWBC Kit by NanoEnTek, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08809317540269 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED ccec7550-29c3-446a-a9b6-cdb9eae077f1 61 fields · synced Jun 18, 2026
- FDA UDI f15d674d-d890-4b79-840f-c0501c3ac977 35 fields · synced May 30, 2026