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 Stratus® CS STAT Fluorometric Analyzer is a microprocessor controlled instrument that measures analytes in body fluids for in vitro diagnostic use. The instrument is intended for use by trained healthcare professionals in the clinical laboratory and point of care settings and is intended for the measurement of the following analytes: High Sensitivity Troponin-I (CTNI), CK-MB Mass (Creatine kinase. MB) (CKMB), Myoglobin (MYO), NT-proBNP (PBNP), D-dimer (DDMR), CardioPhase hsCRP (High Sensitiv
Siemens Healthcare Diagnostics Inc.
10444834
In Commercial Distribution

  • 00842768024863 ()
758000.901

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated
Dimension Vista Barcode Labels
Siemens Healthcare Diagnostics Inc.
10464353
In Commercial Distribution

  • 00842768024719 ()
KS866

  • Printer label IVD
Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10464359
In Commercial Distribution

  • 00842768024214 ()
KC602

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Syva® Emit® II 5B3 THC Assay
Siemens Healthcare Diagnostics Inc.
10445468
Not in Commercial Distribution

  • 00842768023910 ()
9M979UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Emit® II Plus Ecstasy Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445479
In Commercial Distribution

  • 00842768023460 ()
9X229

  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Emit® II Plus Methaqualone Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445476
In Commercial Distribution

  • 00842768023453 ()
9Q229

  • Methaqualone IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Cannabinoid Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445472
In Commercial Distribution

  • 00842768023446 ()
9N229

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Ethyl Alcohol Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445451
In Commercial Distribution

  • 00842768023439 ()
9K229

  • Ethanol (ETOH) IVD, kit, spectrophotometry
Emit® II Plus Phencyclidine Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445444
In Commercial Distribution

  • 00842768023422 ()
9J229

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Cocaine Metabolite Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445440
In Commercial Distribution

  • 00842768023415 ()
9H229

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
Emit ® II Plus Propoxyphene Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445436
In Commercial Distribution

  • 00842768023408 ()
9G229

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Benzodiazepine Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445432
In Commercial Distribution

  • 00842768023392 ()
9F229

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Methadone Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445231
In Commercial Distribution

  • 00842768023385 ()
9E229

  • Methadone IVD, kit, enzyme immunoassay (EIA)
Emit ® II Plus Barbiturate Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445425
In Commercial Distribution

  • 00842768023378 ()
9D229

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)
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® II Plus Opiate Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445415
In Commercial Distribution

  • 00842768023354 ()
9B229

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
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)
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