Revogene C. difficile 401300

GUDID 00840733102349

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.

MERIDIAN BIOSCIENCE, INC.

Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00840733102349
NIH Device Record Key3eae486e-3afb-4bdc-8542-51ed4fe2baca
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevogene C. difficile
Version Model Number410300
Catalog Number401300
Company DUNS092815364
Company NameMERIDIAN BIOSCIENCE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com
Phone1-800-343-3858
EmailMBI-TechService@meridianbioscience.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733102349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZNC. Difficile Toxin Gene Amplification Assay

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-23
Device Publish Date2020-07-15

Devices Manufactured by MERIDIAN BIOSCIENCE, INC.

00840733103025 - Para-Pak Modified (Cu) PVA2023-10-25 Para-Pak based systems provide standardized procedures for the routine collection, transportation, preservation, and examination
00840733101472 - Premier HpSA Flex2023-09-05 The Premier HpSA Flex enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori ant
00840733101410 - Meridian Viral Transport2023-08-15 Meridian Viral Transport is a system which contains all materials necessary to collect and transport clinical specimens for vira
00840733103308 - Curian Shiga Toxin 2023-06-05 The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simulta
00840733102387 - Curian Campy2023-03-31 Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campyloba
00840733103285 - Revogene Check2022-07-05 The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm th
00840733102844 - Para-Pak SAF2022-04-01 The Para-Pak SAF is a convenient system for the routine collection, transportation, preservation, and examination of stool speci
00840733101434 - BreathTek UBT for H. pylori 2022-02-21 The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated wi

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.