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iotaSOFT Console
Iotamotion, Inc.
IM-02
In Commercial Distribution
- 00850002960020 ()
- Robotic surgical system application software
iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution
- 00850002960006 ()
- Robotic surgical system application software
iotaSOFT Plus Drive Unit
Iotamotion, Inc.
IM-05
In Commercial Distribution
- 00850002960068 ()
- Robotic surgical system application software
An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
NANO-DITECH CORPORATION
TF8147
In Commercial Distribution
- 00895160002526 ()
- 10895160002523 ()
TF8147
- Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of an
electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to
orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
1026
In Commercial Distribution
- B54010260 ()
1026
- Thermal cycler nucleic acid amplification analyser IVD, point-of-care
ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.
Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs.
MERIDIAN BIOSCIENCE, INC.
782030
In Commercial Distribution
- 00840733101656 ()
782030
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
Nasopharyngeal Wash/Aspirate Kit for use with ImmunoCard STAT! FLU A&B.
ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.
Moderate Complexity when used with Nasal Wash/Aspirate Samples.
MERIDIAN BIOSCIENCE, INC.
781130
In Commercial Distribution
- 00840733101649 ()
781130
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens.
Alere Scarborough, Inc.
575-000
In Commercial Distribution
- 10811877010972 ()
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
A rapid test for the qualitative detection of Influenza A & B Antigens in nasal swab specimens.
Alere Scarborough, Inc.
412-000
Not in Commercial Distribution
- 10811877010873 ()
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens
Alere Scarborough, Inc.
575-000
Not in Commercial Distribution
- 10811877010156 ()
- Influenza A/B virus antigen IVD, kit, rapid ICT, clinical