Catalog Number

07RD7021

Brand Name

QuickProfile™ PCP Test Strip

Version/Model Number

07RD7021

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

LCM

Product Code Name

Enzyme Immunoassay, Phencyclidine

Public Device Record Key

5dee32f8-56c9-4195-85fe-374f5311942d

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 15, 2017

Package DI Number

M90107RD70211

Quantity per Package

50

Contains DI Package

M90107RD70210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK