CRL STAT Cup - DOA 7 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, - CLINICAL REFERENCE LABORATORY, INC.

Duns Number:098268311

Device Description: DOA 7 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC300 MET1000 O DOA 7 in 1 Test CRL Stat Cup W/ AD, CLIA Waived, 25Pcs/Box, BAR300 BZO300 COC300 MET1000 OPI2000 PCP25 THC50 & pH SG OX CR NI

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More Product Details

Catalog Number

-

Brand Name

CRL STAT Cup

Version/Model Number

KCUR920081

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)

Yes

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

45944f1b-ea34-4b5e-bc6b-8276ed0c120d

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

March 15, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLINICAL REFERENCE LABORATORY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18