Identity
- Trade Name
- LipidPlus® Total Cholesterol Test Strips FDA UDI
- Generic Name
- Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid FDA UDI
- Device Name
- Lipid and Glucose Measuring System FDA UDI
- Model / Reference
- MD532 FDA UDI
- Description
- Lipid and Glucose Measuring System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10763924532107 FDA UDI
- FDA Product Code
- CHH FDA UDI
- GMDN Term
- Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1175 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Microliter FDA UDI
Category: Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapid
LipidPlus® Total Cholesterol Test Strips by Jant Pharmacal Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Jant Pharmacal Corp.
Sources (1)
- FDA UDI bf0bce25-636a-4131-aa61-68616b49360a 35 fields · synced Jun 8, 2026