Xpert Xpress Strep A - Xpert Xpress Strep A kit; 120 test kit - CEPHEID

Duns Number:956711444

Device Description: Xpert Xpress Strep A kit; 120 test kit

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More Product Details

Catalog Number

XPRSTREPA-120

Brand Name

Xpert Xpress Strep A

Version/Model Number

XPRSTREPA-120

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PGX

Product Code Name

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Device Record Status

Public Device Record Key

19d737be-3066-4277-8871-709fae46291c

Public Version Date

May 02, 2022

Public Version Number

2

DI Record Publish Date

June 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CEPHEID" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 53
2 A medical device with a moderate to high risk that requires special controls. 78