Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
- Device Name
- This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. 4 x 0.5ml FDA UDI
- Model / Reference
- H7541-CAL FDA UDI
- Description
- This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. 4 x 0.5ml FDA UDI
Identifiers
- Catalog Number
- H7541-CAL FDA UDI
- Primary DI / UDI-DI
- 00811727011534 FDA UDI
- 510(k) Number
- K031539 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, calibrator 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, calibrator
Pointe Scientific, Inc. 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, calibrator.
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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 Reagent — POINTE SCIENTIFIC, INC.
- Pointe HbA1c for the BS480 — 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 c0d5d3a4-0842-4854-8a6b-425dc8cc8774 37 fields · synced Jun 8, 2026