Identity
- Trade Name
- MedTest DX autoHDL for PC180 FDA UDI
- Generic Name
- Total fatty acid IVD, reagent FDA UDI
- Device Name
- For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Polychem 180 analyzer. For in vitro diagnostic use only. 3 x 51 ml, 2 x 20 ml FDA UDI
- Model / Reference
- HDL505 FDA UDI
- Description
- For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Polychem 180 analyzer. For in vitro diagnostic use only. 3 x 51 ml, 2 x 20 ml FDA UDI
Identifiers
- Catalog Number
- HDL505 FDA UDI
- Primary DI / UDI-DI
- 00817439021151 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 for PC180 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtest DX
Sources (1)
- FDA UDI 4d2c242c-9142-4326-929d-f68dd77fbc0d 37 fields · synced Jun 1, 2026