Identity
- Trade Name
- Pointe Scientific, Inc. Glyco Resin FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
- Device Name
- Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus. 1 x 120 ml FDA UDI
- Model / Reference
- 13-G7540-RES-120 FDA UDI
- Description
- Reagent for the quantitative determination of Glycohemoglobin (HbA1) in blood by cation exchange resin. The test is to be used to monitor long-term glucose control in diabetes mellitus. 1 x 120 ml FDA UDI
Identifiers
- Catalog Number
- 13-G7540-RES-120 FDA UDI
- Primary DI / UDI-DI
- 00811727014238 FDA UDI
- 510(k) Number
- K860572 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, reagent 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, reagent
Pointe Scientific, Inc. Glyco Resin by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K860572 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 1d9a9742-b42b-4b3f-aa14-1473b02ccb77 37 fields · synced May 30, 2026