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No Description
GREAT BASIN SCIENTIFIC, INC.
GBGBS-10
In Commercial Distribution
- B178GBGBS100 ()
- B178GBGBS102 ()
GBGBS-10
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Bion Enterprises, Ltd.
QAB-1504
In Commercial Distribution
- B110QAB15040 ()
QAB-1504
- Influenza A/B virus antigen IVD, control
The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
INFG0300
In Commercial Distribution
- ENTIINFG03000 ()
INFG0300
- Influenza B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
C. diff Assay Cartridge and Sample Prep Device.
GREAT BASIN SCIENTIFIC, INC.
GBCDIFF-10
In Commercial Distribution
- B178GBCDIFF100 ()
- B178GBCDIFF102 ()
GBCDIFF-10
- Clostridium difficile toxin B nucleic acid IVD, kit, nucleic acid technique (NAT)
- Clostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT)
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)
No Description
Bion Enterprises, Ltd.
CBN-3310
Not in Commercial Distribution
- B110CBN33100 ()
CBN-3310
- Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CBG-3320
Not in Commercial Distribution
- B110CBG33200 ()
CBG-3320
- Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
IB-2112
In Commercial Distribution
- B110IB21120 ()
IB-2112
- Influenza B virus immunoglobulin G (IgG) antibody IVD, reagent