Identity
- Trade Name
- Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
- Device Name
- The Dropper A1c Diabetes Control is intended for the quality control of analytical procedures used to quantitate HbA1c. It is supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. It consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the methods indicated in the product insert. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth. FDA UDI
- Model / Reference
- 1510-02 FDA UDI
- Description
- The Dropper A1c Diabetes Control is intended for the quality control of analytical procedures used to quantitate HbA1c. It is supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. It consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the methods indicated in the product insert. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth. FDA UDI
Identifiers
- Catalog Number
- 1510-02 FDA UDI
- Primary DI / UDI-DI
- 00896863002066 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
No
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
Dropper A1c Diabetes Control Level 1&2 Set 4x0.9mL by Quantimetrix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, control.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- HbA1C CONTROL — Randox Laboratories, Ltd. · Class I
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- HbA1c — POINTE SCIENTIFIC, INC. · Class II
- 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
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quantimetrix Corp.
Sources (1)
- FDA UDI f4a66630-648c-4d64-b4e4-27a58fcd947a 36 fields · synced Jun 6, 2026