DOA 3 PANEL TEST - Immunoassay for the detection of the following - RAPID DIAGNOSTICS INC

Duns Number:008028248

Device Description: Immunoassay for the detection of the following drug substance(s) in human urine: AMP / OPI Immunoassay for the detection of the following drug substance(s) in human urine: AMP / OPI / THC

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More Product Details

Catalog Number

07RD7062-13

Brand Name

DOA 3 PANEL TEST

Version/Model Number

07RD7062-13

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

LDJ

Product Code Name

ENZYME IMMUNOASSAY, CANNABINOIDS

Device Record Status

Public Device Record Key

fab72b91-62af-41b7-a3a9-44a45f7ffbb8

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RAPID DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 250
U Unclassified 1