Identity
- Trade Name
- Sirrus® Direct Gylcohemoglobin (HbA1c) FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood. FDA UDI
- Model / Reference
- S0360-200 FDA UDI
- Description
- For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood. FDA UDI
Identifiers
- Catalog Number
- S0360-200 FDA UDI
- Primary DI / UDI-DI
- 00657498001523 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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, kit, nephelometry/turbidimetry
Sirrus® Direct Gylcohemoglobin (HbA1c) by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry.
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- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Tina-quant Hemoglobin A1cDx Gen.3 — Roche Diagnostics Corp. · Class II
- Tinaquant Hemoglobin A1c Gen2 Whole blood and Hemolysate Application — Roche Diagnostics Corp. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
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
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI aca935fe-9314-48d9-86f0-28adb4d1b556 36 fields · synced May 30, 2026