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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.
GenePoc Inc
133674
Not in Commercial Distribution
- 00628055344087 ()
133674
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
SCIMEDX CORPORATION
I-OTS01X
In Commercial Distribution
- 00813545026066 ()
I-OTS01X
- Orientia tsutsugamushi immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-ECH01X
In Commercial Distribution
- 00813545025649 ()
I-ECH01X
- Ehrlichia chaffeensis immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase
chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and
influenza B viral RNA. The Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs and
symptoms of respiratory infection. Accula Flu A / B assay is intended as an aid in the diagnosis of influenza infections
in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza
C virus.
MESA BIOTECH, INC.
FAB1100CW
In Commercial Distribution
- B540FAB1100CW0 ()
FAB1100CW
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase
chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and
influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and
symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections
in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza
C virus.
MESA BIOTECH, INC.
1035
In Commercial Distribution
- B54010350 ()
1035
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerase
chain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A and
influenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs and
symptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infections
in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza
C virus.
MESA BIOTECH, INC.
1027
In Commercial Distribution
- B54010270 ()
1027
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana Infulenza A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M300
In Commercial Distribution
- 30014613336068 ()
M300
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Lyra FLU A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M100
In Commercial Distribution
- 30014613311003 ()
M100
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent
Beckman Coulter, Inc.
447480
In Commercial Distribution
- 15099590233242 ()
447480
- Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, enzyme immunoassay (EIA)
Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
Not in Commercial Distribution
- 07332940001070 ()
GXFLU-10A
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)