Rapid Response - One Step 10 Panel DOA Cup (10.32) - COC300 - BTNX Inc

Duns Number:251005005

Device Description: One Step 10 Panel DOA Cup (10.32) - COC300 MET1000 AMP1000 OPI2000 OXY100 MTD300 PCP25 BAR One Step 10 Panel DOA Cup (10.32) - COC300 MET1000 AMP1000 OPI2000 OXY100 MTD300 PCP25 BAR300 BZO300 MDMA500

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More Product Details

Catalog Number

-

Brand Name

Rapid Response

Version/Model Number

D10.32-1V

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180349

Product Code Details

Product Code

NFT

Product Code Name

Test, Amphetamine, Over The Counter

Device Record Status

Public Device Record Key

011a281e-293f-4a5f-8f97-cccbb85211f7

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BTNX INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 27