QuikStrip MultiDrug X Screening Dip Card - QuikStrip Multidrug 1 Screening Dip Card Test - - SYNTRON BIORESEARCH, INC.

Duns Number:174517060

Device Description: QuikStrip Multidrug 1 Screening Dip Card Test - MAD 300 ng/ml

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More Product Details

Catalog Number

-

Brand Name

QuikStrip MultiDrug X Screening Dip Card

Version/Model Number

30121

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K061617,K061617

Product Code Details

Product Code

DJR

Product Code Name

Enzyme Immunoassay, Methadone

Device Record Status

Public Device Record Key

90c59798-0fb0-4118-b6b5-2b24d163b9ea

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 04, 2016

Additional Identifiers

Package DI Number

10748349000189

Quantity per Package

25

Contains DI Package

00748349000182

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Kit Box

"SYNTRON BIORESEARCH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 28