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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Emit® tox Salicylic Acid Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445394
In Commercial Distribution

  • 00842768023347 ()
7S229

  • Salicylate IVD, kit, enzyme immunoassay (EIA)
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)
Emit® 2000 Vancomycin Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445338
In Commercial Distribution

  • 00842768023323 ()
4W229

  • Vancomycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Gentamicin Plus Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445335
In Commercial Distribution

  • 00842768023316 ()
4T229

  • Gentamicin therapeutic drug monitoring IVD, calibrator
Emit® 2000 Tobramycin Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445332
In Commercial Distribution

  • 00842768023309 ()
4S229

  • Tobramycin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Quinidine Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445329
In Commercial Distribution

  • 00842768023293 ()
4Q229

  • Quinidine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Theophylline Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445326
In Commercial Distribution

  • 00842768023286 ()
4P229

  • Theophylline therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 N-Acetylprocainamide Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445323
In Commercial Distribution

  • 00842768023279 ()
4N229

  • N-acetyl procainamide (NAPA) IVD, kit, fluorescent immunoassay
Emit® 2000 Procainamide Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445320
In Commercial Distribution

  • 00842768023262 ()
4K229

  • Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Digoxin Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445317
In Commercial Distribution

  • 00842768023255 ()
4H229

  • Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit ® 2000 Valproic Acid Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445314
In Commercial Distribution

  • 00842768023248 ()
4G229

  • Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Carbamazepine Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445311
In Commercial Distribution

  • 00842768023231 ()
4F229

  • Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Phenobarbital Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445308
In Commercial Distribution

  • 00842768023224 ()
4D229

  • Phenobarbital IVD, kit, enzyme immunoassay (EIA)
Emit® 2000 Phenytoin Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445305
In Commercial Distribution

  • 00842768023217 ()
4A229

  • Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Herpes-2 IgG (HSV2) Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
10733034
In Commercial Distribution

  • 00842768022838 ()
10733034

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
Herpes-2 IgG (HSV2) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10733033
In Commercial Distribution

  • 00842768022807 ()
10733033

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Herpes-1 IgG (HSV1) Atellica IM - Quality Control
Siemens Healthcare Diagnostics Inc.
10733032
In Commercial Distribution

  • 00842768022791 ()
10733032

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control
Herpes-1 IgG (HSV1) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10733031
In Commercial Distribution

  • 00842768022784 ()
10733031

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Anti-HBe2 (aHBe2) – Atellica IM – QC Kit
Siemens Healthcare Diagnostics Inc.
10733022
In Commercial Distribution

  • 00842768022685 ()
10733022

  • Hepatitis B virus e-antigen total antibody IVD, control
Anti-HBe2 (aHBe2) – Atellica IM – RGT 50T
Siemens Healthcare Diagnostics Inc.
10733021
In Commercial Distribution

  • 00842768022678 ()
10733021

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
AMH – Atellica IM – RGT – 100T
Siemens Healthcare Diagnostics Inc.
10998433
In Commercial Distribution

  • 00842768022401 ()
10998433

  • Anti-Mullerian hormone (AMH) IVD, kit, chemiluminescent immunoassay
AMH – Atellica IM - Master Curve Material Kit 4 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10998431
In Commercial Distribution

  • 00842768022395 ()
10998431

  • Anti-Mullerian hormone (AMH) IVD, control
Sirolimus Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10464327
In Commercial Distribution

  • 00842768022128 ()
DC306

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator
Sirolimus Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10464331
In Commercial Distribution

  • 00842768022111 ()
  • 00630414005546 ()
DF306

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
LOCI Free Thyroxine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10464523
In Commercial Distribution

  • 00842768022098 ()
  • 00630414005652 ()
RF610

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
LOCI Thyroid Stimulating Hormone Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10464524
In Commercial Distribution

  • 00842768022081 ()
  • 00630414005669 ()
RF612

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
LOCI Cardiac Troponin I Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10464336
In Commercial Distribution

  • 00842768022074 ()
RC621

  • Troponin I IVD, calibrator
Cardiac Troponin I Flex® reagent cartridge, 144 tests
Siemens Healthcare Diagnostics Inc.
10464525
In Commercial Distribution

  • 00842768022067 ()
  • 00630414005676 ()
RF621

  • Troponin I IVD, kit, chemiluminescent immunoassay
Ethyl Alcohol Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10459408
In Commercial Distribution

  • 00842768022050 ()
  • 00630414005447 ()
DF22

  • Ethanol (ETOH) IVD, kit, spectrophotometry
High Density Lipoprotein Cholesterol Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10464332
In Commercial Distribution

  • 00842768022029 ()
  • 00630414005553 ()
DF48B

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
AHDL Calibrator, 2x3x1mL
Siemens Healthcare Diagnostics Inc.
10464328
In Commercial Distribution

  • 00842768022012 ()
DC48B

  • High density lipoprotein (HDL) cholesterol IVD, calibrator
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)
Direct Bilirubin Flex® reagent cartridge, 320 tests
Siemens Healthcare Diagnostics Inc.
10444956
In Commercial Distribution

  • 00842768020551 ()
  • 00630414004389 ()
DF125

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Total Bilirubin Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10444957
In Commercial Distribution

  • 00842768020544 ()
  • 00630414004402 ()
DF167

  • Total bilirubin IVD, kit, spectrophotometry
Lipid Calibrator, 3x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10464345
In Commercial Distribution

  • 00842768020452 ()
KC220A

  • Multiple lipid analyte IVD, calibrator
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
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
Siemens Healthcare Diagnostics Inc.
10445455
In Commercial Distribution

  • 00842768020315 ()
9L039UL

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, kit, enzyme immunoassay (EIA)
Liquid Lipase Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10461745
Not in Commercial Distribution

  • 00842768020223 ()
  • 00630414005485 ()
K3056

  • Lipase IVD, kit, spectrophotometry
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
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