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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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Syva® Emit® II Plus Ecstasy Assay - 00842768021947

Syva® Emit® II Plus Ecstasy Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445478
In Commercial Distribution

  • 00842768021947 ()
9X129UL

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

Dimension® Flex® reagent cartridge DBI - 00842768020551

Direct Bilirubin Flex® reagent cartridge, 320 tests
Siemens Healthcare Diagnostics Inc.
10444956
In Commercial Distribution

  • 00842768020551 ()
  • 00630414004389 ()
DF125

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge TBI - 00842768020544

Total Bilirubin Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444957
In Commercial Distribution

  • 00842768020544 ()
  • 00630414004402 ()
DF167

  • Total bilirubin IVD, kit, spectrophotometry

Dimension Vista® LIPID CAL - 00842768020452

Lipid Calibrator, 3x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10464345
In Commercial Distribution

  • 00842768020452 ()
KC220A

  • Multiple lipid analyte IVD, calibrator

Dimension Vista® Flex® reagent cartridge HDLC - 00842768020438

High Density Lipoprotein Cholesterol Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10464340
In Commercial Distribution

  • 00842768020438 ()
  • 00630414005584 ()
K3048A

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge IRON - 00842768020414

Iron Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10444945
In Commercial Distribution

  • 00842768020414 ()
  • 00630414004327 ()
DF85

  • Iron IVD, kit, spectrophotometry

Syva® Emit® II LSD Assay - 00842768020315

Syva® Emit® II LSD Assay
Siemens Healthcare Diagnostics Inc.
10445455
In Commercial Distribution

  • 00842768020315 ()
9L039UL

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® Flex® reagent cartridge LIPL - 00842768020223

Liquid Lipase Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10461745
Not in Commercial Distribution

  • 00842768020223 ()
  • 00630414005485 ()
K3056

  • Lipase IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge AFP - 00842768019937

Alpha-Fetoprotein Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10463378
In Commercial Distribution

  • 00842768019937 ()
  • 00630414005515 ()
K6454

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge CEA - 00842768019920

Carcinoembryonic Antigen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10461744
In Commercial Distribution

  • 00842768019920 ()
  • 00630414005478 ()
K6453

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
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