Identity
- Trade Name
- LipidPlus® Meter FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) monitoring system IVD, home-use FDA UDI
- Device Name
- Lipid and Glucose Measuring System FDA UDI
- Model / Reference
- MD550 FDA UDI
- Description
- Lipid and Glucose Measuring System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10763924550507 FDA UDI
- FDA Product Code
- JJX FDA UDILBR FDA UDIJGY FDA UDICHH FDA UDICGA FDA UDINBW FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI862.1475 FDA UDI862.1705 FDA UDI862.1175 FDA UDI862.1345 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Glycated haemoglobin (HbA1c) monitoring system IVD, home-useGlycated haemoglobin (HbA1c) monitoring system IVD, point-of-careHome-use/point-of-care blood glucose/ketone monitoring system IVD
LipidPlus® Meter by Jant Pharmacal Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care.
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- BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer — Wuxi Biohermes Bio & Medical Technology Co., Ltd.
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 9162d105-0f41-4cbc-a103-a37397979360 34 fields · synced May 31, 2026