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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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frCRP - 05055273201789

The CRP test system is intended for the quantitative in vitro determination of C-Reactive Protein (CRP) concentration in serum or plasma.
RANDOX LABORATORIES LIMITED
CP3849
In Commercial Distribution

  • 05055273201789 ()
CP3849

  • C-reactive protein (CRP) IVD, reagent

frCRP - 05055273201772

The CRP test system is intended for the quantitative in vitro determination of C-Reactive Protein (CRP) concentration in serum or plasma.
RANDOX LABORATORIES LIMITED
CP3847
In Commercial Distribution

  • 05055273201772 ()
CP3847

  • C-reactive protein (CRP) IVD, reagent

C4 - 05055273201628

A Complement C4 test system is a device intended for the quantitative in vitro determination of Complement C4 concentration in serum
RANDOX LABORATORIES LIMITED
CM3846
In Commercial Distribution

  • 05055273201628 ()
CM3846

  • Complement components C4/C4c IVD, reagent

C3 - 05055273201611

A Complement C3 test system is a device intended for the quantitative in vitro determination of Complement C3 concentration in serum
RANDOX LABORATORIES LIMITED
CM3845
In Commercial Distribution

  • 05055273201611 ()
CM3845

  • Complement component C3 proactivator IVD, reagent

Ca - 05055273200911

The calcium test system is a device intended for the quantitative in vitro determination of calcium in serum, plasma or urine
RANDOX LABORATORIES LIMITED
CA590
In Commercial Distribution

  • 05055273200911 ()
CA590

  • Calcium (Ca2+) IVD, reagent

AMY - 05055273200652

An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, or urine.
RANDOX LABORATORIES LIMITED
AY7932
In Commercial Distribution

  • 05055273200652 ()
AY7932

  • Amylase isoenzyme IVD, reagent

ALB - 05055273200058

An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.
RANDOX LABORATORIES LIMITED
AB3800
In Commercial Distribution

  • 05055273200058 ()
AB3800

  • Albumin IVD, reagent

ALB - 05055273200041

An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.
RANDOX LABORATORIES LIMITED
AB362
In Commercial Distribution

  • 05055273200041 ()
AB362

  • Albumin IVD, reagent

ALB - 05055273200034

An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.
RANDOX LABORATORIES LIMITED
AB3800
In Commercial Distribution

  • 05055273200034 ()
AB3800

  • Albumin IVD, reagent

QuPID® Plus Sample Pack - 00657498002056

For the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy.
STANBIO LABORATORY, L.P.
1230-003
In Commercial Distribution

  • 00657498002056 ()
  • 00657498002049 ()
1230-003

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
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