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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 Class Implantable

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Syva® Emit® II Plus Amphetamines Assay - 00842768001857

Syva® Emit® II Plus Amphetamines Assay - 115 mL
Siemens Healthcare Diagnostics Inc.
10445420
In Commercial Distribution

  • 00842768001857 ()
9C309UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® tox™ Acetaminophen Assay - 00842768001550

Syva® Emit® tox Acetaminophen Assay
Siemens Healthcare Diagnostics Inc.
10445385
In Commercial Distribution

  • 00842768001550 ()
7A319UL

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® Amikacin Assay - 00842768001543

Syva® Emit® Amikacin Assay
Siemens Healthcare Diagnostics Inc.
10445383
In Commercial Distribution

  • 00842768001543 ()
6X019UL

  • Amikacin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Emit® II Plus Amphetamines Assay - 00842768023361

Emit ® II Plus Amphetamines Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445419
In Commercial Distribution

  • 00842768023361 ()
9C229

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

Emit® tox™ Acetaminophen Assay - 00842768023330

Emit® tox Acetaminophen Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445384
In Commercial Distribution

  • 00842768023330 ()
7A229

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)

CLINITEK Novus® Automated Urine Chemistry Analyzer - 00630414981147

The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10697937
In Commercial Distribution

  • 00630414981147 ()
10697937

  • Urine analyser IVD, laboratory

CLINITEK Novus® Automated Urine Chemistry Analyzer - 00630414981130

The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10494134
In Commercial Distribution

  • 00630414981130 ()
10494134

  • Urine analyser IVD, laboratory

Atellica IM Calibrator Y - 00630414598475

Calibrator Y - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995520
In Commercial Distribution

  • 00630414598475 ()
  • 00630414190914 ()
10995520

  • Complexed prostate specific antigen (cPSA) IVD, calibrator

Atellica CH UA - 00630414596334

Uric Acid (UA) Atellica CH - RGT 4800T
Siemens Healthcare Diagnostics Inc.
11097608
In Commercial Distribution

  • 00630414596334 ()
11097608

  • Uric acid IVD, kit, spectrophotometry

Atellica CH Amp - 00630414596068

Amphetamine (Amp) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097506
In Commercial Distribution

  • 00630414596068 ()
11097506

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
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