Identity
- Trade Name
- Drew Scientific FDA UDI
- Generic Name
- Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- Gold Kit 80-100 Test FDA UDI
- Model / Reference
- 014-080 FDA UDI
- Description
- Gold Kit 80-100 Test FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274020135 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, control 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
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: Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, control
Drew Scientific by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Echinococcus granulosus immunoglobulin G (IgG) antibody IVD, control.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 01718706-2a1b-459c-a751-bcea7a6ed9e6 35 fields · synced Jun 8, 2026