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ONLINE DAT Cannabinoids II

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
ONLINE DAT Cannabinoids II FDA UDI
Generic Name
Cannabinoid/cannabinoid metabolite IVD, reagent FDA UDI
Model / Reference
08058644190 FDA UDI

Identifiers

Catalog Number
08058644190 FDA UDI
Primary DI / UDI-DI
07613336121511 FDA UDI
510(k) Number
K030213 FDA UDI
FDA Product Code
LDJ FDA UDI
GMDN Term
Cannabinoid/cannabinoid metabolite IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3870 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cannabinoid/cannabinoid metabolite IVD, reagent

ONLINE DAT Cannabinoids II by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cannabinoid/cannabinoid metabolite IVD, reagent.

Cleared under the same submission

K030213 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI c32d6942-d4a4-43f3-a443-f6f1e688561d 35 fields · synced May 29, 2026