Identity
- Trade Name
- Pointe HbA1c Reagent FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
- Device Name
- Pointe HbA1c Reagent packaged for use on the Mindray BA800. 10 x 15ml R1, 5 x 10ml R2. 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
- 16-H7546-200 FDA UDI
- Description
- Pointe HbA1c Reagent packaged for use on the Mindray BA800. 10 x 15ml R1, 5 x 10ml R2. 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
- 16-H7546-200 FDA UDI
- Primary DI / UDI-DI
- 00811727016164 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, control
Pointe HbA1c Reagent by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glycated haemoglobin (HbA1c) IVD, control.
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- 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.
- HbA1c — 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 67805297-c04b-4e68-adda-5ad81d1d552c 36 fields · synced May 30, 2026