A rapid, automated, molecular test for the qualitative detection of inuenza A and B viral nucleic acid in respiratory specimens.

Control Swabs intended for use only with the ID NOW Influenza A & B 2 product.

Control Swabs intended for use only with the Alere i Inuenza A & B product.

A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.

A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.

Control Swabs intended for use only with the ID NOW RSV product.

Control Swabs intended for use only with the Alere i RSV product.

A rapid, automated, molecular test for the qualitative detection of Streptococcus pyogenes Group A bacterial nucleic acid in throat swab specimens.

Control Swabs intended for use only with the Alere i Strep A product.

A rapid, automated, molecular test for the qualitative detection of Streptococcus pyogenes Group A bacterial nucleic acid in throat swab specimens.

Control Swabs intended for use only with the ID NOW Strep A 2 product.

Control Swabs intended for use only with the Alere i Strep A 2 product.

BD MAX™ GBS

Instrument Max Clinical

Instrument Max Clinical Refurb

Instrument Bd Viper LT System

BD Pre-Warm Heater

BD Viper™ LT System SDA Accessory Kit

Kit BD MAX Enteric Parasite Panel

Kit BD MAX Enteric Bacterial Panel

BD MAX™ StaphSR

BD MAX™ MRSA XT

BD MAX™ Vaginal Panel

Kit BD MAX Enteric Viral Panel

Savanna Instrument

Savanna Instrument

Kit BD Max Enteric Bacterial Panel USA

BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer

The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.

The MOCK PIE is a re-usable PIE intended for use in conjunction with the revogene™ instrument and GenePOC assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower then eight in a run.

The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The GenePOC Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC Carba assay result does not preclude the presence of other resistance mechanisms.The GenePOC Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.

The GenePOC Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The GenePOC Strep A assay is intended for use as an aid in the diagnosis of Group A Streptococcus infection.

Panther® Instrument System.

The Panther Fusion® Flu A/B/RSV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).

The Panther Fusion® Paraflu assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus (HPIV-1, HPIV-2, HPIV-3, and HPIV-4).

The Panther Fusion® AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV).

Panther Fusion® Flu A/B/RSV Controls Kit.

Panther Fusion® Paraflu Controls Kit.

Panther Fusion® AdV/hMPV/RV Controls Kit.

The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing realtime PCR for detection of Group B Streptococcus DNA.

Panther Fusion® GBS Controls Kit.

The Revogene® GBS LB assay performed on the Revogene instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from 18-24 hour LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women. The Revogene GBS LB assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome.The Revogene GBS LB assay is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The MOCK PIE is a re-usable PIE intended for use in conjunction with the Revogene® instrument and Revogene® assays. The MOCK PIE simulates the presence of an assay PIE for thermal and rotational balance when the number of assay PIEs is lower than eight in a run.

The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR.

QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.