Etest® ERAVACYCLINE

GUDID 03573026560997

Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

BIOMERIEUX SA

Antibacterial minimum inhibitory concentration (MIC) IVD
Primary Device ID03573026560997
NIH Device Record Key2427d61a-10c7-455d-8070-d57bfbdf17fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameEtest® ERAVACYCLINE
Version Model NumberEtest® ERAVACYCLINE
Company DUNS276816717
Company NameBIOMERIEUX SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103573026560997 [Package]
Contains: 03573026563585
Package: [30 Units]
In Commercial Distribution
GS103573026563585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWYManual antimicrobial susceptibility test systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

Devices Manufactured by BIOMERIEUX SA

03573026560997 - Etest® ERAVACYCLINE2019-11-27Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.
03573026560997 - Etest® ERAVACYCLINE2019-11-27 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.
03573026444204 - VIDAS® C. difficile GDH2019-11-27 VIDAS ® C. difficile GDH is is a qualitative test for use on VIDAS family instruments to detect C. difficile antigen
03573026156961 - VIDAS® Prolactin2019-11-27 VIDAS ® Prolactin (PRL) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of prolactin concentration in human serum or plasma .
03573026121631 - VIDAS® QCV2019-11-27 Automated test for use on the VIDAS® system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems.
03573026073589 - Trypcase Soy Broth2019-11-21 Trypcase Soy broth is a culture medium for the growth of most non-fastidious micro-organisms (bacteria and fungi)
03573026229146 - VIDAS® C. difficile Toxin A & B2019-11-18 The VIDAS ® C. difficile Toxin A & B is a test for use on VIDAS family instruments for the qualitative detection of Clostridium difficile toxin A and B in stool specimens
03573026156930 - VIDAS® LH2019-11-13 VIDAS® LH (LH) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of LH concentration in human serum or plasma .
03573026551544 - Etest® IMIPENEM RELEBACTAM2019-11-06 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

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