Identity
- Trade Name
- Drew Scientific FDA UDI
- Generic Name
- Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- DS5 Pink Kit (300 test) FDA UDI
- Model / Reference
- 014-350 FDA UDI
- Description
- DS5 Pink Kit (300 test) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274020173 FDA UDI
- 510(k) Number
- K933287 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical
Drew Scientific by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hepatitis C virus total antibody IVD, kit, rapid ICT, clinical.
- OraQuick HCV Rapid Antibody Test — OraSure Technologies, Inc. · Class II
- Drew Scientific — 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 5e56422f-fc3d-4a99-8e03-cd7848bd0fcb 36 fields · synced Jun 1, 2026