MDx-Chex for BC-GP 250079

GUDID 00844509002468

MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis, Enterococcus faecium, Streptococcus anginosus group; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.; antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.

STRECK, INC.

Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control Multiple-type bloodstream pathogen nucleic acid IVD, control
Primary Device ID00844509002468
NIH Device Record Key627324f4-a695-4931-b1a6-9884012595f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMDx-Chex for BC-GP
Version Model Number250079
Catalog Number250079
Company DUNS072915986
Company NameSTRECK, 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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100844509002468 [Primary]

FDA Product Code

PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-17
Device Publish Date2023-08-09

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