Identity
- Trade Name
- Direct Lipid Control Set FDA UDI
- Generic Name
- Multiple lipid analyte IVD, control FDA UDI
- Device Name
- This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems. 6 x 3 ml FDA UDI
- Model / Reference
- 3000 FDA UDI
- Description
- This product is intended for in-vitro use only, in the quality control of Direct HDL, Direct LDL, Lipoprotein (a), and Apolipoprotein A-1, Apolipoprotein B, cholesterol and triglyceride methods on clinical chemistry systems. 6 x 3 ml FDA UDI
Identifiers
- Catalog Number
- 3000 FDA UDI
- Primary DI / UDI-DI
- 00817439020000 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple lipid analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Direct Lipid Control Set by Medtest DX — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medtest DX
Sources (1)
- FDA UDI 9f8d1c6c-8fd9-4edb-a0f3-2f779aafd142 37 fields · synced May 30, 2026