Identity
- Trade Name
- Direct A1c Calibrator Kit FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, calibrator FDA UDI
- Device Name
- Calibrator intended to establish known points of reference for use with Direct A1c Reagent Kit 55370. FDA UDI
- Model / Reference
- 55120 FDA UDI
- Description
- Calibrator intended to establish known points of reference for use with Direct A1c Reagent Kit 55370. FDA UDI
Identifiers
- Catalog Number
- 55120 FDA UDI
- Primary DI / UDI-DI
- 03661540304293 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Direct A1c Calibrator Kit by Elitechgroup Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Glycated haemoglobin (HbA1c) IVD, calibrator.
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- HbA1C CAL — Randox Laboratories, Ltd. · Class II
- Chemistry HbA1c Calibrator Kit — Medica Corp. · Class II
- VARIANT II — Bio-Rad Laboratories · Class I
- Trinity Biotech — Primus Corp. · Class II
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 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.
- 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
- Elitechgroup Inc.
Sources (1)
- FDA UDI a29ecf75-0698-43aa-8577-3c2a36d383df 35 fields · synced May 30, 2026