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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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The Jasper HPLC system is a high pressure liquid chromatography system for clinical use intended to separate one or more compounds from a solution by processing the mixture of compounds (solutes) through a column packed with a solid absorbent material (stationary phase) under the influence of a high pressure liquid (mobile phase). This system is intended to be used in tandem with a mass spectrometer system for compound detection.
AB SCIEX (MANUFACTURING)
5057029
In Commercial Distribution

  • 00842365100519 ()


  • High performance liquid chromatography analyser IVD
No Description
AB SCIEX (MANUFACTURING)
5050412
Not in Commercial Distribution

  • 00842365100038 ()


  • Mass spectrometry analyser IVD
No Description
Orasure Technologies, Inc.
1103IC
In Commercial Distribution

  • 00608337000153 ()


  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1103IB
In Commercial Distribution

  • 00608337000146 ()


  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® II Plus Amphetamines Assay - 1L Kit
Siemens Healthcare Diagnostics Inc.
10445421
In Commercial Distribution

  • 00842768001864 ()
9C329UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
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
Siemens Healthcare Diagnostics Inc.
10445385
In Commercial Distribution

  • 00842768001550 ()
7A319UL

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® Amikacin Assay
Siemens Healthcare Diagnostics Inc.
10445383
In Commercial Distribution

  • 00842768001543 ()
6X019UL

  • Amikacin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5052-3
In Commercial Distribution

  • 00842430105807 ()
5052-3

  • Limb/torso/head restraint, single-use
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)
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