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No Description
Lgc Clinical Diagnostics, Inc.
2000-0101
In Commercial Distribution
- 00850041090009 ()
- Multiple infectious organism/newborn TORCH screen IVD, control
Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Acon Laboratories, Inc.
L031-11711
In Commercial Distribution
- 20682607200973 ()
- 00682607200979 ()
- 00682607002269 ()
200979
- SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Mechanical Diaper Scale
Pelstar, LLC
YG500R
In Commercial Distribution
- 00854896003641 ()
- Laboratory scale, mechanical
Rapid Response H. Pylori Test Cassettes - 15 tests/ kit are for the qualitative detection of antibodies to Helicobacter pylori in whole blood, serum, or plasma.
BTNX Inc
HPY-13C15
In Commercial Distribution
- 00722066000304 ()
- 00722066004258 ()
HPY-13C15
- Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
EIA Color Developer, 13.0 mL
MARDX DIAGNOSTICS, INC.
40-1006
In Commercial Distribution
- 05391516747714 ()
40-1006
- Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
- Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ToRCH EBV Positive Control is intended for use with in vitro assays for determination of IgG and IgM antibodies to the viral capsid antigen of Epstein-Barr Virus (EBV VCA) and IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA).
ToRCH EBV Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.
ToRCH EBV Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10350
In Commercial Distribution
- 05055273216431 ()
SR10350
- Multiple infectious organism/newborn TORCH screen IVD, control
ToRCH IgM Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2.
ToRCH IgM Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.
ToRCH IgM Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10349
In Commercial Distribution
- 05055273216424 ()
SR10349
- Multiple infectious organism/newborn TORCH screen IVD, control
ToRCH IgG Positive Control is intended for use with in vitro assays for determination of IgG antibodies to Cytomegalovirus (CMV), IgG antibodies to Rubella Virus, IgG antibodies to Toxoplasma gondii, IgG antibodies to Herpes Simplex Virus Type 1 and 2, IgG antibodies to Mumps Virus, IgG antibodies to Measles Virus, IgG antibodies to Varicella Zoster Virus, IgG antibodies to Helicobacter pylori IgG antibodies to Treponema pallidum (Syphilis), IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH IgG Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay.
ToRCH IgG Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10348
In Commercial Distribution
- 05055273216417 ()
SR10348
- Multiple infectious organism/newborn TORCH screen IVD, control
ToRCH Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting IgG and IgM antibodies to Cytomegalovirus (CMV), IgG and IgM antibodies to Rubella virus, IgG and IgM antibodies to Toxoplasma gondii, IgG and IgM antibodies to Herpes Simplex Type 1 and 2, IgG antibodies to Mumps Virus, IgG antibodies to Rubeola Virus (Measles), IgG antibodies to Varicella Zoster Virus, IgG antibodies to Helicobacter pylori, IgG antibodies to Treponema pallidum (Syphilis), IgG and IgM antibodies to the Viral Capsid Antigen of Epstein-Barr virus (EBV VCA) and IgG antibodies to the Viral Polypeptide Nuclear Antigen of Epstein-Barr Virus (EBV EBNA IgG).
RANDOX LABORATORIES LIMITED
SR10347
In Commercial Distribution
- 05055273216400 ()
SR10347
- Multiple infectious organism/newborn TORCH screen IVD, control
No Description
ALERE SAN DIEGO, INC.
01P53-25
Not in Commercial Distribution
- 10815845020079 ()
- 00815845020072 ()
- Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical