Identity
- Trade Name
- InteliQ FDA UDI
- Generic Name
- Multiple cardiac marker IVD, control FDA UDI
- Device Name
- InteliQ Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers control.) FDA UDI
- Model / Reference
- 12009961 FDA UDI
- Description
- InteliQ Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers control.) FDA UDI
Identifiers
- Catalog Number
- 12009961 FDA UDI
- Primary DI / UDI-DI
- 03610522114382 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Multiple cardiac marker 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
Yes
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
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: Multiple cardiac marker IVD, control
InteliQ by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple cardiac marker IVD, control.
- Audit MicroControls Linearity FLQ Cardiac Markers for Roche Systems — Aalto Scientific, Ltd.
- Audit MicroControls Linearity FD Cardiac Markers for Roche Systems — Aalto Scientific, Ltd.
- CARDIAC MARKER CONTROL TRI-LVL — CLINIQA CORPORATION
- Audit MicroControls Linearity FD Cardiac Markers for Ortho Vitros — Aalto Scientific, Ltd.
- Cardiac Calibration Verifiers for Beckman Systems — CLINIQA CORPORATION · Class I
- Audit MicroControls Linearity FD Cardiac Markers — Aalto Scientific, Ltd.
- Audit MicroControls Linearity FLQ Cardiac Markers for Ortho Vitros — Aalto Scientific, Ltd.
- TRI-LEVEL CARDIAC CONTROL (CRD CONTROL 1, 2, 3) — Randox Laboratories, Ltd. · 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
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 49607b5d-13dd-4ac1-a92b-25fcc2424f84 36 fields · synced May 30, 2026