Identity
- Trade Name
- Drew Scientific FDA UDI
- Generic Name
- Multiple coagulation factor IVD, reagent FDA UDI
- Device Name
- DREW D3 LYTIC REAGENT - Bulk Liquid FDA UDI
- Model / Reference
- R12A24D-BUL FDA UDI
- Description
- DREW D3 LYTIC REAGENT - Bulk Liquid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274020425 FDA UDI
- FDA Product Code
- GGK FDA UDI
- GMDN Term
- Multiple coagulation factor IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple coagulation factor IVD, reagentMultiple blood gas analyte IVD, reagent
Drew Scientific by Drew Scientific , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Drew Scientific — Drew Scientific , Ltd. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 674eb56d-13bb-435c-b1b5-4b2f82e159ed 35 fields · synced Jun 8, 2026