Triage - Triage TOX Drug Screen, 94600 Control 2 - QUIDEL CARDIOVASCULAR INC.

Duns Number:080890141

Device Description: Triage TOX Drug Screen, 94600 Control 2

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More Product Details

Catalog Number

94614

Brand Name

Triage

Version/Model Number

94614

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code Details

Product Code

DIF

Product Code Name

Drug mixture control materials

Device Record Status

Public Device Record Key

2f3af9dc-9f9f-4d7b-b2cd-da9f4fb00c72

Public Version Date

August 01, 2019

Public Version Number

1

DI Record Publish Date

July 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUIDEL CARDIOVASCULAR INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 20