Identity
- Trade Name
- MedTest DX autoHDL / BS200 FDA UDI
- Generic Name
- Total fatty acid IVD, reagent FDA UDI
- Device Name
- HDL600, for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Mindray BS-200 analyzer. For in vitro diagnostic use only. Size: 3 x 51 ml, 2 x 20 ml FDA UDI
- Model / Reference
- HDL600 FDA UDI
- Description
- HDL600, for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Mindray BS-200 analyzer. For in vitro diagnostic use only. Size: 3 x 51 ml, 2 x 20 ml FDA UDI
Identifiers
- Catalog Number
- HDL600 FDA UDI
- Primary DI / UDI-DI
- 00817439020871 FDA UDI
- FDA Product Code
- LBR FDA UDI
- GMDN Term
- Total fatty acid IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 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
MedTest DX autoHDL / BS200 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 9bf1193c-e282-41c7-a9dc-f8eb6f2be136 37 fields · synced May 30, 2026