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B. burgdorferi WB IgG Serum Band Locator, 250µL
MARDX DIAGNOSTICS, INC.
40-2023L
In Commercial Distribution
- 05391516747622 ()
40-2023L
- Legionella pneumophila 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)
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
No Description
DIASORIN SPA
P001925
In Commercial Distribution
- 08056771102308 ()
- Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
20750948322
In Commercial Distribution
- 04015630913770 ()
20750948322
- Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, enzyme immunoassay (EIA)
The ARIES® Group A Strep Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus) in throat swab specimens from patients with signs and symptoms of pharyngitis.
LUMINEX CORPORATION
50-10041
In Commercial Distribution
- 00840487101469 ()
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2189-9601 A
Not in Commercial Distribution
- 04049016027553 ()
- Multiple Brucella species immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)