Revogene C. difficile - The Revogene C. difficile assay performed on the - MERIDIAN BIOSCIENCE, INC.

Duns Number:092815364

Device Description: The Revogene C. difficile assay performed on the Revogene instrument is a qualitative in v The Revogene C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection. The Revogene C. difficile assay is intended to aid in the diagnosis of CDI.

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More Product Details

Catalog Number

401300

Brand Name

Revogene C. difficile

Version/Model Number

410300

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

K172569

Product Code Details

Product Code

OZN

Product Code Name

C. Difficile Toxin Gene Amplification Assay

Device Record Status

Public Device Record Key

3eae486e-3afb-4bdc-8542-51ed4fe2baca

Public Version Date

July 23, 2020

Public Version Number

1

DI Record Publish Date

July 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERIDIAN BIOSCIENCE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 149
2 A medical device with a moderate to high risk that requires special controls. 46
3 A medical device with high risk that requires premarket approval 1