Identity
- Trade Name
- A1c-Cellular Linearity FDA UDI
- Generic Name
- Glycated haemoglobin (HbA1c) IVD, control FDA UDI
- Device Name
- A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linearity assesses the accuracy and linear reportable range of the HbA1c parameter. FDA UDI
- Model / Reference
- 285536 FDA UDI
- Description
- A1c-Cellular Linearity contains one vial each of Levels 1-5. A1c-Cellular Linearity assesses the accuracy and linear reportable range of the HbA1c parameter. FDA UDI
Identifiers
- Catalog Number
- 285536 FDA UDI
- Primary DI / UDI-DI
- 00844509001003 FDA UDI
- 510(k) Number
- K040025 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
Dimensions & Sizes
- Size
- Total Volume — 2.0 Milliliter FDA UDI
Category: Glycated haemoglobin (HbA1c) IVD, control
A1c-Cellular Linearity by Streck — 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
Cleared under the same submission
K040025 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 I | Pending data |
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Manufacturer
- Manufacturer
- Streck
Sources (1)
- FDA UDI 8ad0f517-b14b-4941-ab9b-a5f0dc6c53f5 38 fields · synced Jun 8, 2026