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TOX/See

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
TOX/See FDA UDI
Generic Name
Tricyclic antidepressant IVD, kit, rapid ICT, clinical FDA UDI
Device Name
TOX/See Drug Screen Test TCA FDA UDI
Model / Reference
194-5234 FDA UDI
Description
TOX/See Drug Screen Test TCA FDA UDI

Identifiers

Catalog Number
1945234 FDA UDI
Primary DI / UDI-DI
00847817000768 FDA UDI
FDA Product Code
LFG FDA UDI
GMDN Term
Tricyclic antidepressant IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3910 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

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

Yes

FDA UDI

Category: Tricyclic antidepressant IVD, kit, rapid ICT, clinical

TOX/See by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tricyclic antidepressant IVD, kit, rapid ICT, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 1d7eeab3-c05b-404b-bcf1-8712b161b8e8 36 fields · synced Jun 6, 2026