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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Creatine Kinase Flex® reagent cartridge, 800 Tests
Siemens Healthcare Diagnostics Inc.
10464356
In Commercial Distribution

  • 00842768027925 ()
  • 00630414005607 ()
K2038

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 120 Tests
Siemens Healthcare Diagnostics Inc.
10464339
In Commercial Distribution

  • 00842768027918 ()
  • 00630414005577 ()
K3032

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Lactate Dehydrogenase Flex® reagent cartridge, 800 Tests
Siemens Healthcare Diagnostics Inc.
10464323
In Commercial Distribution

  • 00842768027819 ()
  • 00630414005539 ()
K2054

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
ADVIA 120/2120/2120i RBC Flow Cell Wash Kit
Siemens Healthcare Diagnostics Inc.
10734561
In Commercial Distribution

  • 00630414286938 ()
  • 00842768027369 ()
10734561

  • Wash/cleaning solution IVD, automated/semi-automated system
ADVIA 120/2120/2120i Perox Flow Cell Wash Kit
Siemens Healthcare Diagnostics Inc.
11306489
In Commercial Distribution

  • 00630414287089 ()
  • 00842768027345 ()
11306489

  • Wash/cleaning solution IVD, automated/semi-automated system
ADVIA 120/2120/2120i Aspiration Pathway Wash Kit
Siemens Healthcare Diagnostics Inc.
11306490
In Commercial Distribution

  • 00630414287096 ()
  • 00842768027338 ()
11306490

  • Wash/cleaning solution IVD, automated/semi-automated system
Lactate Dehydrogenase Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10284483
In Commercial Distribution

  • 00842768027314 ()
  • 00630414002965 ()
DF54

  • Total lactate dehydrogenase (LDH) IVD, kit, spectrophotometry
ADVIA 120/2120/2120i Vent Line Wash Kit
Siemens Healthcare Diagnostics Inc.
11306492
In Commercial Distribution

  • 00630414287102 ()
  • 00842768027307 ()
11306492

  • Wash/cleaning solution IVD, automated/semi-automated system
Enzyme 5 Calibrator, 3x1.5mL
Siemens Healthcare Diagnostics Inc.
10464346
In Commercial Distribution

  • 00842768026911 ()
KC350

  • Multiple clinical chemistry enzyme IVD, calibrator
Enzyme 6 Calibrator, 3x2.0mL
Siemens Healthcare Diagnostics Inc.
10464509
In Commercial Distribution

  • 00842768026614 ()
KC360

  • Multiple clinical chemistry enzyme IVD, calibrator
ADVIA Centaur® Zika Ab Assay
Siemens Healthcare Diagnostics Inc.
11200700
Not in Commercial Distribution

  • 00842768026553 ()
11200700

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
LOCI 8 Calibrator, 2x5x2.5mL
Siemens Healthcare Diagnostics Inc.
10488192
In Commercial Distribution

  • 00842768026492 ()
KC646

  • Multiple human hormone IVD, calibrator
LOCI Total Testosterone Flex® reagent cartridge, 320 tests
Siemens Healthcare Diagnostics Inc.
10488399
In Commercial Distribution

  • 00842768026485 ()
  • 00630414016788 ()
K6465

  • Total testosterone IVD, kit, chemiluminescent immunoassay
LOCI Progesterone Flex® reagent cartridge, 320 Tests
Siemens Healthcare Diagnostics Inc.
10461743
In Commercial Distribution

  • 00842768026478 ()
  • 00630414005461 ()
K6464

  • Progesterone IVD, kit, chemiluminescent immunoassay
LOCI Estradiol Flex® reagent cartridge, 320 Tests
Siemens Healthcare Diagnostics Inc.
10489099
In Commercial Distribution

  • 00842768026461 ()
  • 00630414005850 ()
K6463

  • Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
LOCI Prolactin Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10488398
In Commercial Distribution

  • 00842768026454 ()
  • 00630414005812 ()
K6462

  • Prolactin IVD, kit, chemiluminescent immunoassay
LOCI Luteinizing Hormone Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10488534
In Commercial Distribution

  • 00842768026447 ()
  • 00630414005836 ()
K6461

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
LOCI Follicle Stimulating Hormone Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10488533
In Commercial Distribution

  • 00842768026430 ()
  • 00630414005829 ()
K6460

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10464529
In Commercial Distribution

  • 00842768026324 ()
RC623

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator
Enzyme I Calibrator, 2x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10284680
In Commercial Distribution

  • 00842768026218 ()
  • 00630414602004 ()
DC35

  • Multiple clinical chemistry enzyme IVD, calibrator
Creatine Kinase MB Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10464510
In Commercial Distribution

  • 00842768025556 ()
  • 00630414005638 ()
DF32

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry
CKI/MBI Calibrator, 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10464508
In Commercial Distribution

  • 00842768025549 ()
DC32

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
Lipase Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10460277
In Commercial Distribution

  • 00842768025532 ()
  • 00630414005454 ()
DF56

  • Lipase IVD, kit, spectrophotometry
Creatine Kinase Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10464511
In Commercial Distribution

  • 00842768025525 ()
  • 00630414005645 ()
DF38

  • Total creatine kinase (CK) IVD, kit, spectrophotometry
Enzymatic Creatinine Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10464578
Not in Commercial Distribution

  • 00842768025419 ()
KC270

  • Creatinine IVD, calibrator
ADVIA Centaur Zika Test - Zika Ab Controls
Siemens Healthcare Diagnostics Inc.
11200712
Not in Commercial Distribution

  • 00842768025273 ()
11200712

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
Lipase Calibrator, 2x3x1mL
Siemens Healthcare Diagnostics Inc.
10460278
In Commercial Distribution

  • 00842768025228 ()
DC56

  • Lipase IVD, calibrator
Drug 3 Calibrator- Level A - 6x2mL, Level B 3x1.5ml, Level C 3X1.5 mL
Siemens Healthcare Diagnostics Inc.
10285194
Not in Commercial Distribution

  • 00842768025211 ()
KC430A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator
Cyclosporine Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10285193
In Commercial Distribution

  • 00842768025136 ()
  • 00630414002972 ()
DF89A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
N-terminal Pro-Brain Natriuretic Peptide Calibrator, 2x6x1mL
Siemens Healthcare Diagnostics Inc.
10464322
In Commercial Distribution

  • 00842768025129 ()
KC676A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator
NT-proBNP Flex® reagent cartridge, 80 Tests
Siemens Healthcare Diagnostics Inc.
10464321
In Commercial Distribution

  • 00842768025112 ()
  • 00630414005522 ()
K6423A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
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)
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