Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
- Device Name
- Liquid Hemoglobin A1c Control Set, The HbA1c controls are reference controls consisting of human blood based solutions. It is intended to simulate human patient whole blood samples for the purpose of monitoring the precision of laboratory testing procedures for the following assays: HbA1c. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. Size: 4 x 0.5 mL FDA UDI
- Model / Reference
- H7546-CTL FDA UDI
- Description
- Liquid Hemoglobin A1c Control Set, The HbA1c controls are reference controls consisting of human blood based solutions. It is intended to simulate human patient whole blood samples for the purpose of monitoring the precision of laboratory testing procedures for the following assays: HbA1c. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. Size: 4 x 0.5 mL FDA UDI
Identifiers
- Catalog Number
- H7546-CTL FDA UDI
- Primary DI / UDI-DI
- 00811727014566 FDA UDI
- 510(k) Number
- K952720 FDA UDI
- FDA Product Code
- JPK FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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Implantable
No
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Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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Convenience Kit
Yes
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Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
Yes
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Manufacturing Date
No
FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, control
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, 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.
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 4c50ab10-349b-4abf-9802-1476b8cfb23d 37 fields · synced May 30, 2026