ONLINE DAT Cannabinoids II - Roche Diagnostics GmbH

Duns Number:315028860

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More Product Details

Catalog Number

08771669190

Brand Name

ONLINE DAT Cannabinoids II

Version/Model Number

08771669190

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 03, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K030213

Product Code Details

Product Code

LDJ

Product Code Name

Enzyme immunoassay, cannabinoids

Device Record Status

Public Device Record Key

953f0548-c4f9-4433-8fce-60d527334d0c

Public Version Date

November 27, 2020

Public Version Number

2

DI Record Publish Date

March 05, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ROCHE DIAGNOSTICS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 289
2 A medical device with a moderate to high risk that requires special controls. 760
3 A medical device with high risk that requires premarket approval 63
U Unclassified 4