Identity
- Trade Name
- HbA1c FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
- Device Name
- For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 12-H7541-40 FDA UDI
- Description
- For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 12-H7541-40 FDA UDI
- Primary DI / UDI-DI
- 00811727013545 FDA UDI
- 510(k) Number
- K031539 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 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
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
Category: Glycated haemoglobin (HbA1c) IVD, control
HbA1c by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, control.
- HbA1C CONTROL — Randox Laboratories, Ltd. · Class I
- MAS Diabetes Max, Multi-pack — Microgenics Corporation · Class I
- MULTI-SYSTEM Hb A1c CAPILLARY CONTROLS (2) — Sebia, Inc. · Class I
- PreciControl HbA1c path — Roche Diagnostics Corp. · Class I
- Liquichek — Bio-Rad Laboratories · Class I
- Liquid Glycated Haemoglobin (HbA1c) Control Level 2 (LIQ HbA1c CONTROL LEVEL 2) — Randox Laboratories, Ltd. · Class I
- Liquichek — Bio-Rad Laboratories · Class I
- Diazyme — Diazyme Laboratories, Inc.
Cleared under the same submission
K031539 also covers:
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- Direct A1c Calibrator Kit — ELITECHGROUP INC.
- Direct A1c Control Kit — ELITECHGROUP INC.
- Direct A1c Reagent Kit — ELITECHGROUP INC.
- HbA1c — POINTE SCIENTIFIC, INC.
- Pointe HbA1c Reagent — POINTE SCIENTIFIC, INC.
- Pointe HbA1c for the BS480 — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI fbd3cf54-34b7-40bd-a1ea-6be049eb76ec 37 fields · synced May 29, 2026