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No Description
Microgenics Corporation
100012
In Commercial Distribution
- 00884883001299 ()
- Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
HEMOSTAT, KELLY STRAIGHT
STRADIS MEDICAL, LLC
ZZ-0700
Not in Commercial Distribution
- M752ZZ07001 ()
- M752ZZ07000 ()
- Rhinovirus immunoglobulin A (IgA)/IgG antibody IVD, control
The Anti-Lea reagent (Anti-LE1) is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
ALBA BIOSCIENCE LIMITED
6904557
In Commercial Distribution
- 10758750013104 ()
- Anti-Le^a red blood cell grouping IVD, antibody
The Anti-Fya reagent (Anti-FY1) is for the qualitative in vitro detection of human Fya positive red blood cells by the indirect
antiglobulin test.
ALBA BIOSCIENCE LIMITED
6904546
In Commercial Distribution
- 10758750013005 ()
- Anti-Fy^a red blood cell grouping IVD, antibody
The NATtrol™ Influenza A/B Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Influenza A/B Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Influenza A/B Positive Control
In Commercial Distribution
- 01220000260085 ()
NATFLUAB-6C-IVD
- Influenza A/B virus nucleic acid IVD, control
The NATtrol™ Influenza/RSV Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Influenza/RSV Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.
ZEPTOMETRIX CORPORATION
NATtrol™ Influenza/RSV Negative Control
In Commercial Distribution
- 01220000260078 ()
NATCXVA9-6C-IVD
- Influenza A/B virus nucleic acid IVD, control
No Description
Orasure Technologies, Inc.
1001-0323
In Commercial Distribution
- 00608337000054 ()
- Nasopharyngeal aspirate container IVD
- Influenza A/B virus antigen IVD, reagent
- Influenza A/B virus antigen IVD, control
BioSign Flu Control Kit (5 Postive/ 5 Negative)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-03
In Commercial Distribution
- 10743816001492 ()
BSP-510C-03
- Nasopharyngeal aspirate container IVD
- Influenza A/B virus antigen IVD, reagent
- Influenza A/B virus antigen IVD, control
Status Flu Control Kit (5 Flu A/5 Flu B)
PRINCETON BIOMEDITECH CORPORATION
BSP-510C-02
In Commercial Distribution
- 10743816001423 ()
BSP-510C-02
- Nasopharyngeal aspirate container IVD
- Influenza A/B virus antigen IVD, reagent
- Influenza A/B virus antigen IVD, control
InnoVoyce VYLO Eye Safety Filter Leica
Innovoyce LLC
A
In Commercial Distribution
- 00860004755999 ()
ASY-300143
- General/multiple surgical laser system beam guide, reusable