Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Multichannel immunoassay analyser IVD FDA UDI
- Device Name
- D3 Hematology Analyzer FDA UDI
- Model / Reference
- BAS-9001-181 FDA UDI
- Description
- D3 Hematology Analyzer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274021491 FDA UDI
- 510(k) Number
- K071562 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- Multichannel immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multichannel immunoassay analyser IVD
JAS Diagnostics by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- JAS Diagnostics — Drew Scientific , Ltd. · Class I
- Drew — Drew Scientific , Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 863b6c1b-2ef5-42ad-96e0-fd0546eae867 36 fields · synced May 30, 2026