Identity
- Trade Name
- A1CNow® Self Check Test System FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) monitoring system IVD, home-use FDA UDI
- Device Name
- The A1CNow® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples. FDA UDI
- Model / Reference
- 3030 FDA UDI
- Description
- The A1CNow® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples. FDA UDI
Identifiers
- Catalog Number
- 3030 FDA UDI
- Primary DI / UDI-DI
- 00381933030013 FDA UDI
- 510(k) Number
- K090413 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) monitoring system IVD, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 FDA UDI
- Commercial Distribution
- Not 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
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
A1CNow® Self Check Test System by Polymer Technology Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K090413 also covers:
- Hopkins Medical Products® — HOPKINS UNIFORM COMPANY
- A1CNow Self Check, 8ct. — Polymer Technology Systems
- A1CNow® Self Check Test System — Polymer Technology Systems
- A1CNow®+ Multi-Use Test System (10 count) — Polymer Technology Systems
- A1CNow®+ Multi-UseTest System (20 count) — Polymer Technology Systems
- TRUE+ A1CNow Self Check — Polymer Technology Systems
- Well at Walgreens — WALGREEN CO.
- CVS Health At Home A1C Test Kit — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- CVS Health At Home A1C Test Kit — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- ReliOn™ 2CT A1C Meter — Walmart Stores
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 II | Pending data |
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Manufacturer
- Manufacturer
- Polymer Technology Systems
Sources (1)
- FDA UDI 0e6e5450-8a97-4fbe-b048-ce7e09707c5e 38 fields · synced May 30, 2026