Identity
- Trade Name
- PreciControl TS FDA UDI
- Generic Name
- Multiple thyroid marker IVD, control FDA UDI
- Model / Reference
- 06445918160 FDA UDI
Identifiers
- Catalog Number
- 06445918160 FDA UDI
- Primary DI / UDI-DI
- 04015630936564 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Multiple thyroid 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
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
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 thyroid marker IVD, control
PreciControl TS by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple thyroid marker IVD, control.
- Audit MicroControls Linearity FD Thyroid Siemens Atellica — Aalto Scientific, Ltd.
- LIAISON® CONTROL THYROID 1 — Diasorin Inc.
- LIAISON® CONTROL THYROID 2 — Diasorin Inc.
- Audit MicroControls Linearity FLQ Thyroids for Roche Systems — Aalto Scientific, Ltd.
- LIAISON® CONTROL THYROID 3 — Diasorin Inc.
- Audit MicroControls Linearity FD Thyroid for Abbott Systems — Aalto Scientific, Ltd.
- VITROS — Ortho-Clinical Diagnostics · Class I
- PreciControl ThyroAB — Roche Diagnostics Corp. · 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 |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 27848cf5-df95-4b15-ad05-326eb7593812 34 fields · synced May 31, 2026