MD DrugScreen - CLIA Waived 12 Panel Drug Test Cup - Medical Disposables Corp

Duns Number:961673774

Device Description: CLIA Waived 12 Panel Drug Test Cup w/AD(COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) CLIA Waived 12 Panel Drug Test Cup w/AD(COC/MOP/AMP/MET/BAR/BZO/MDMA/MTD/OXY/PCP/TCA/BUP) Adulterants: CR, S.G., pH

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More Product Details

Catalog Number

-

Brand Name

MD DrugScreen

Version/Model Number

MDC-14125A3A

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

-

Product Code Details

Product Code

LDJ

Product Code Name

Enzyme Immunoassay, Cannabinoids

Device Record Status

Public Device Record Key

aca0aaad-32fa-4df7-aea0-5f3fabcd3366

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

January 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAL DISPOSABLES CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 221
U Unclassified 17