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ADAM-rWBC2 & ADAM-rWBC Kit
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref ADAM-rWBC2 & ADAM-rWBC Kit
Identity
- Trade Name
- ADAM-rWBC2 System FDA UDI
- Generic Name
- White blood cell count IVD, kit, cell count FDA UDI
- Device Name
- ADAM-rWBC2 System is composted ADAM-rWBC2(equipment) and ADAM-rWBC Kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in the human specimen. FDA UDI
- Model / Reference
- ADAM-rWBC2 & ADAM-rWBC Kit EUDAMEDADAM-rWBC2 System FDA UDI
- Description
- ADAM-rWBC2 System is composted ADAM-rWBC2(equipment) and ADAM-rWBC Kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in the human specimen. FDA UDI
Identifiers
- Catalog Number
- ADAM-rWBC2 System FDA UDI
- Primary DI / UDI-DI
- 08809317540504 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809317540504 EUDAMED
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W0103010199,W0202010101 EUDAMED
- GMDN Term
- White blood cell count IVD, kit, cell count FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- Greece 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ADAM-rWBC2 & 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-08809317540504 | 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 76218748-1c3c-4e6e-955c-156f4b669b10 61 fields · synced Jul 9, 2026
- FDA UDI b2b8faa7-6b24-4b48-8513-5cd9940f653f 35 fields · synced May 30, 2026