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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Acid Wash Solution should be used in conjunction with reagents to clean probes and cuvettes
RANDOX LABORATORIES LIMITED
RX8129
In Commercial Distribution

  • 05055273215021 ()
RX8129

  • Wash/cleaning solution IVD, automated/semi-automated system
Alkaline Wash Solution should be used in conjunction with reagents to clean cuvettes
RANDOX LABORATORIES LIMITED
RX8130
In Commercial Distribution

  • 05055273215007 ()
RX8130

  • Wash/cleaning solution IVD, automated/semi-automated system
No Description
RANDOX LABORATORIES LIMITED
AO2802
In Commercial Distribution

  • 05055273213928 ()


  • Adiponectin IVD, control
No Description
RANDOX LABORATORIES LIMITED
AO2801
In Commercial Distribution

  • 05055273213911 ()


  • Adiponectin IVD, control
No Description
RANDOX LABORATORIES LIMITED
AO2800
In Commercial Distribution

  • 05055273213904 ()


  • Adiponectin IVD, calibrator
Alkaline Detergent is used for cleaning the instrument probe and reaction cuvettes.
RANDOX LABORATORIES LIMITED
RX8108
In Commercial Distribution

  • 05055273210385 ()
RX8108

  • Wash/cleaning solution IVD, automated/semi-automated system
Antibacterial Detergent is used for cleaning the instrument probe and reaction cuvettes.
RANDOX LABORATORIES LIMITED
RX8106
In Commercial Distribution

  • 05055273210378 ()
RX8106

  • Wash/cleaning solution IVD, automated/semi-automated system
No Description
RANDOX LABORATORIES LIMITED
UA8333
In Commercial Distribution

  • 05055273209570 ()


  • Uric acid IVD, kit, spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
UA8069
In Commercial Distribution

  • 05055273209563 ()


  • Uric acid IVD, kit, spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
LP8008
In Commercial Distribution

  • 05055273209228 ()


  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LP8007
In Commercial Distribution

  • 05055273209211 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LP5047
In Commercial Distribution

  • 05055273209204 ()


  • Multiple apolipoprotein IVD, calibrator
No Description
RANDOX LABORATORIES LIMITED
LO8305
In Commercial Distribution

  • 05055273209181 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LO8015
In Commercial Distribution

  • 05055273209174 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LE5018
In Commercial Distribution

  • 05055273209129 ()


  • Multiple apolipoprotein IVD, control
No Description
RANDOX LABORATORIES LIMITED
LE5017
In Commercial Distribution

  • 05055273209112 ()


  • Multiple apolipoprotein IVD, control
No Description
RANDOX LABORATORIES LIMITED
LE5016
In Commercial Distribution

  • 05055273209105 ()


  • Multiple apolipoprotein IVD, control
No Description
RANDOX LABORATORIES LIMITED
AS8005
In Commercial Distribution

  • 05055273208238 ()


  • Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AP8302
In Commercial Distribution

  • 05055273208207 ()


  • Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AL8304
In Commercial Distribution

  • 05055273208160 ()


  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AL8006
In Commercial Distribution

  • 05055273208153 ()


  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AC8001
In Commercial Distribution

  • 05055273208122 ()


  • Total acid phosphatase (TAP) IVD, kit, spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
LP3867
In Commercial Distribution

  • 05055273204506 ()


  • Apolipoprotein A-II (Apo A2) IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LP3866
In Commercial Distribution

  • 05055273204490 ()


  • Apolipoprotein C-II (Apo C2) IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LP3865
In Commercial Distribution

  • 05055273204483 ()


  • Apolipoprotein C-III (Apo C3) IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LP3864
In Commercial Distribution

  • 05055273204476 ()


  • Apolipoprotein E (Apo E) IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LO3998
In Commercial Distribution

  • 05055273204315 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
The Randox Ammonia Ethanol Control - Level 3 is intended for in vitro diagnostic use, in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
EA1368
In Commercial Distribution

  • 05055273202113 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
The Randox Ammonia Ethanol Control - Level 2 is intended for in vitro diagnostic use, in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
EA1367
In Commercial Distribution

  • 05055273202106 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
The Randox Ammonia Ethanol Control Level 1 is intended for in vitro diagnostic use, in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
EA1366
In Commercial Distribution

  • 05055273202090 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
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