QuikScreen - QuikScreen Multi 9+1 Drug Cup Test - AMP 1000, - SYNTRON BIORESEARCH, INC.

Duns Number:174517060

Device Description: QuikScreen Multi 9+1 Drug Cup Test - AMP 1000, BUP 10, BZD 300, COC 300, MAD 300, MET 1000 QuikScreen Multi 9+1 Drug Cup Test - AMP 1000, BUP 10, BZD 300, COC 300, MAD 300, MET 1000, OPI 300, OPI 2000, OXY 100 + ALC

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More Product Details

Catalog Number

-

Brand Name

QuikScreen

Version/Model Number

65917-19

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

K071489,K122064,K130275,K071489,K122064,K130275,K130275,K122064,K071489

Product Code Details

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

6cc06cb6-6bc7-498c-b20f-dfef666399e4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 02, 2016

Additional Identifiers

Package DI Number

20748349000223

Quantity per Package

4

Contains DI Package

10748349000226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"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