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The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-011-020
Not in Commercial Distribution
- 00857573006294 ()
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
NANOSPHERE, INC.
20-011-023
Not in Commercial Distribution
- 00857573006089 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The AMH Control Level 3 (AMH10515) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 3 (AMH10515) is assayed with target values and is suitable for use on automated analysers.
The AMH Control Level 3 (AMH10515) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
AMH10515
In Commercial Distribution
- 05055273217797 ()
AMH10515
- Anti-Mullerian hormone (AMH) IVD, control
The AMH Control Level 2 (AMH10514) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 2 (AMH10514) is assayed with target values and is suitable for use on automated analysers.
The AMH Control Level 2 (AMH10514) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
AMH10514
In Commercial Distribution
- 05055273217780 ()
AMH10514
- Anti-Mullerian hormone (AMH) IVD, control
The AMH Control Level 1 (AMH10509) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 1 (AMH10509) is assayed with target values and is suitable for use on automated analysers.
The AMH Control Level 1 (AMH10509) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
AMH10509
In Commercial Distribution
- 05055273217773 ()
AMH10509
- Anti-Mullerian hormone (AMH) IVD, control
The AMH Control Level 4 (AMH10516) is intended for use with in vitro diagnostic assays for the quantitative determination of Anti-Müllerian Hormone in human serum and plasma. The AMH Control Level 4 (AMH10516) is assayed with target values and is suitable for use on automated analysers.
The AMH Control Level 4 (AMH10516) is for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
AMH10516
In Commercial Distribution
- 05055273217766 ()
AMH10516
- Anti-Mullerian hormone (AMH) IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10431
In Commercial Distribution
- 05055273217674 ()
CQ10431
- Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10430
In Commercial Distribution
- 05055273217667 ()
CQ10430
- Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10429
In Commercial Distribution
- 05055273217650 ()
CQ10429
- Multiple cardiac marker IVD, control
This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10428
In Commercial Distribution
- 05055273217346 ()
CQ10428
- Multiple cardiac marker IVD, control