MD DrugScreen - CLIA Waived 8 Panel Cup - Medical Disposables Corp

Duns Number:961673774

Device Description: CLIA Waived 8 Panel Cup w/6-AD(THC50/COC150/OPI300/AMP500/MET500/OXY100/MDMA500/PCP25)+ (N CLIA Waived 8 Panel Cup w/6-AD(THC50/COC150/OPI300/AMP500/MET500/OXY100/MDMA500/PCP25)+ (NIT-GLUT-CRE/OXI-SG-PH)

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More Product Details

Catalog Number

-

Brand Name

MD DrugScreen

Version/Model Number

MDC-585-AD

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

LAF

Product Code Name

Gas Chromatography, Methamphetamine

Device Record Status

Public Device Record Key

a2d077be-e736-43c5-9787-04aa9d3a735a

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

April 06, 2018

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