Express ResultsTM - DUA-1107-061 - Quest Diagnostics

Duns Number:189222334

Device Description: DUA-1107-061 (Ox/SG/pH)+(mAMP/OPI/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)+<PPX> 5 MULTI-DRUG 10 P DUA-1107-061 (Ox/SG/pH)+(mAMP/OPI/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)+<PPX> 5 MULTI-DRUG 10 PANEL UDOA-12CE-0712-01 (Previous GTIN 10869419000219)

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More Product Details

Catalog Number

DUA-1107-061-19-ONW504A

Brand Name

Express ResultsTM

Version/Model Number

UDOA-10CA-0503-01

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

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

0d308715-d962-41fb-bc34-c7fc57ec3073

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUEST DIAGNOSTICS" 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. 10
U Unclassified 1