Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Insulin IVD, control FDA UDI
- Device Name
- Alinity i Insulin Controls FDA UDI
- Model / Reference
- 04T7510 FDA UDI
- Description
- Alinity i Insulin Controls FDA UDI
Identifiers
- Catalog Number
- 04T7510 FDA UDI
- Primary DI / UDI-DI
- 00380740150808 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Insulin 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Insulin IVD, control
Alinity by Abbott — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin IVD, control.
- Insulin control slides — BIO SB, INC. · Class I
- K-ASSAY® Insulin Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- IMMULITE® Systems INS Calibration Verification Material Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Insulin control slides — BIO SB, INC. · Class I
- IMMULITE® INS Control Insulin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Diazyme — Diazyme Laboratories, Inc.
- Audit MicroControls Linearity FD Special Diabetes for Ortho Vitros — Aalto Scientific, Ltd.
- Atellica IM IRI MCM — Siemens Healthcare Diagnostics · 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
- Abbott
Sources (1)
- FDA UDI 42be8f8e-309e-4b22-8a4c-a014f2d555b0 36 fields · synced Jun 1, 2026