Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
- Device Name
- Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 2 x 1.0ml FDA UDI
- Model / Reference
- G7540-2 FDA UDI
- Description
- Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 2 x 1.0ml FDA UDI
Identifiers
- Catalog Number
- G7540-2 FDA UDI
- Primary DI / UDI-DI
- 00811727011336 FDA UDI
- 510(k) Number
- K920449 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
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.
Cleared under the same submission
K920449 also covers:
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 84cfc857-c0df-4ac3-8645-0bc20905ff19 37 fields · synced Jun 6, 2026