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Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, reagent FDA UDI
- Device Name
- Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. FDA UDI
- Model / Reference
- G560-125 FDA UDI
- Description
- Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. FDA UDI
Identifiers
- Catalog Number
- G560-125 FDA UDI
- Primary DI / UDI-DI
- 10673486001792 FDA UDI
- 510(k) Number
- K051200 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
Teco Diagnostics Hemoglobin A1c (HbA1c) Reagent Set by Teco Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, reagent.
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- ACE — Alfa Wassermann, Inc. · Class II
- Trinity Biotech — Primus Corp. · Class II
- D-10 — Bio-Rad Laboratories · Class II
Cleared under the same submission
K051200 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
- Teco Diagnostics
Sources (1)
- FDA UDI 6d236357-dbbb-45b7-a54b-69e18769469f 37 fields · synced Jun 1, 2026