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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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LDH P-L - 05055273204117

A lactate dehydrogenase test system is a device intended for the quantitative in vitro determination of Lactate Dehydrogenase (LD) activity in serum or plasma.
RANDOX LABORATORIES LIMITED
LD3818
In Commercial Distribution

  • 05055273204117 ()
LD3818

  • Total lactate dehydrogenase (LDH) IVD, reagent

IgE - 05055273203929

An IgE test system is a device intended for the quantitative in vitro determination of immunoglobulin E (IgE) concentration in human serum or plasma
RANDOX LABORATORIES LIMITED
IE7308
In Commercial Distribution

  • 05055273203929 ()
IE7308

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, reagent

ARC InstaTemp Non-Touch Infrared Thermometer - 05391525574011

The ARC InstaTemp MD Digital Non-Touch Infrared Thermometer is intended to be used in the clinical setting to measure temperature in infants and adults.
ARC DEVICES USA INC
401
In Commercial Distribution

  • 05391525574011 ()


  • Infrared patient thermometer, skin

CRP - 05055273201741

The device is a latex agglutination slide test intended for qualitative and semi-quantitative in vitro diagnostic determination of C-Reactive Protein (CRP) concentration in serum.
RANDOX LABORATORIES LIMITED
CP2714
In Commercial Distribution

  • 05055273201741 ()
CP2714

  • C-reactive protein (CRP) IVD, reagent

CRP - 05055273201642

The device is a latex agglutination slide test intended for qualitative and semi-quantitative in vitro diagnostic determination of C-Reactive Protein (CRP) concentration in serum.
RANDOX LABORATORIES LIMITED
CP1423
In Commercial Distribution

  • 05055273201642 ()
CP1423

  • C-reactive protein (CRP) IVD, reagent

ALP - 05055273200393

An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
RANDOX LABORATORIES LIMITED
AP7927
In Commercial Distribution

  • 05055273200393 ()
AP7927

  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent

ALP - 05055273200362

An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
RANDOX LABORATORIES LIMITED
AP3877
In Commercial Distribution

  • 05055273200362 ()
AP3877

  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent

ALP - 05055273200348

An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
RANDOX LABORATORIES LIMITED
AP3802
In Commercial Distribution

  • 05055273200348 ()
AP3802

  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent

ALP - 05055273200331

An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
RANDOX LABORATORIES LIMITED
AP313
In Commercial Distribution

  • 05055273200331 ()
AP313

  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent

ALP - 05055273200324

An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
RANDOX LABORATORIES LIMITED
AP311
In Commercial Distribution

  • 05055273200324 ()
AP311

  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent
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