Alere iCup Dx - Drugs of Abuse Test Cup for detection of - Instant Technologies, Inc.

Duns Number:019410187

Device Description: Drugs of Abuse Test Cup for detection of (BZO/BAR)+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP Drugs of Abuse Test Cup for detection of (BZO/BAR)+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+COC with adulteration tests Cr, Ni, pH, Bl, S.G., CLIA Waived

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More Product Details

Catalog Number

I-DXA-1117-131

Brand Name

Alere iCup Dx

Version/Model Number

I-DXA-1117-131

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

K052115

Product Code Details

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

3379254a-dc04-45a6-a7b3-73d9506c52e5

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSTANT TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 122
U Unclassified 1