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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
DIASORIN SPA
P001928
In Commercial Distribution
- 08056771102339 ()
- Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN S.P.A.
318110
In Commercial Distribution
- 28056771103583 ()
- 08056771103589 ()
- Hepatitis B virus surface antigen IVD, reagent
No Description
DIASORIN SPA
318140
In Commercial Distribution
- 08056771103381 ()
- 18056771103388 ()
- Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
A rapid, automated, molecular test for the qualitative detection of inuenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
425-024
Not in Commercial Distribution
- 10811877010804 ()
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
In Commercial Distribution
- 10811877010422 ()
- Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
Alere Scarborough, Inc.
427-000
Not in Commercial Distribution
- 10811877010019 ()
- 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