SEARCH RESULTS FOR: siemens(7217 results)

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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® 2000 Sirolimus Calibrators - 00842768029622

Syva® Emit® 2000 Sirolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445402
In Commercial Distribution

  • 00842768029622 ()
8S109UL

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Sirolimus Assay - 00842768029615

Syva® Emit® 2000 Sirolimus Assay
Siemens Healthcare Diagnostics Inc.
10445401
In Commercial Distribution

  • 00842768029615 ()
8S019UL

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® LOCI 7 CAL - 00842768029332

LOCI 7 Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10488446
In Commercial Distribution

  • 00842768029332 ()
KC605

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® LOCI 6 CAL - 00842768029325

LOCI 6 Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10488444
In Commercial Distribution

  • 00842768029325 ()
KC604

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® Small Sample Container (SSC) - 00842768028915

Small Sample Container (SSC), 1000 Pieces
Siemens Healthcare Diagnostics Inc.
10472099
In Commercial Distribution

  • 00842768028915 ()
  • 00630414005720 ()
KS860

  • Assay container IVD, single-use

Dimension Vista® Flex® reagent cartridge CA19-9 - 00842768028533

LOCI CA 19-9 Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10464358
In Commercial Distribution

  • 00842768028533 ()
  • 00630414005621 ()
K6457

  • Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge CA15-3 - 00842768028526

LOCI CA 15-3 Flex® reagent cartridge, 160 Tests
Siemens Healthcare Diagnostics Inc.
10464344
In Commercial Distribution

  • 00842768028526 ()
  • 00630414005591 ()
K6456

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge CA125 - 00842768028519

LOCI CA 125 Flex® reagent cartridge, 160 Tests
Siemens Healthcare Diagnostics Inc.
10464357
In Commercial Distribution

  • 00842768028519 ()
  • 00630414005614 ()
K6455

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge DIGXN - 00842768028335

LOCI Digoxin Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10488927
In Commercial Distribution

  • 00842768028335 ()
  • 00630414005843 ()
K6435

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay

Dimension Vista® Flex® reagent cartridge CKI - 00842768027925

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

Dimension Vista® Flex® reagent cartridge MBI - 00842768027918

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)

Dimension Vista® Flex® reagent cartridge LDI - 00842768027819

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 - 00842768027369

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 120/212-/2120i Perox Flow Cell Wash Kit - 00842768027345

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 - 00842768027338

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

Dimension® LDI Flex® reagent cartridge - 00842768027314

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 - 00842768027307

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

Dimension Vista® ENZ 5 CAL - 00842768026911

Enzyme 5 Calibrator, 3x1.5mL
Siemens Healthcare Diagnostics Inc.
10464346
In Commercial Distribution

  • 00842768026911 ()
KC350

  • Multiple clinical chemistry enzyme IVD, calibrator

Dimension Vista® ENZ 6 CAL - 00842768026614

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 100T - 00842768026553

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

Dimension Vista® LOCI 8 CAL - 00842768026492

LOCI 8 Calibrator, 2x5x2.5mL
Siemens Healthcare Diagnostics Inc.
10488192
In Commercial Distribution

  • 00842768026492 ()
KC646

  • Multiple human hormone IVD, calibrator

Dimension Vista® Total Testosterone Flex® Reagent Cartridge - 00842768026485

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

Dimension Vista® Flex® reagent cartridge PROG - 00842768026478

LOCI Progesterone Flex® reagent cartridge, 320 Tests
Siemens Healthcare Diagnostics Inc.
10461743
In Commercial Distribution

  • 00842768026478 ()
  • 00630414005461 ()
K6464

  • Progesterone IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge E2 - 00842768026461

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

Dimension Vista® Flex® reagent cartridge PRL - 00842768026454

LOCI Prolactin Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10488398
In Commercial Distribution

  • 00842768026454 ()
  • 00630414005812 ()
K6462

  • Prolactin IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge LH - 00842768026447

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

Dimension Vista® Flex® reagent cartridge FSH - 00842768026430

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

Dimension® NTP CAL - 00842768026324

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

Dimension® ENZ 1 CAL - 00842768026218

Enzyme I Calibrator, 2x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10284680
In Commercial Distribution

  • 00842768026218 ()
  • 00630414602004 ()
DC35

  • Multiple clinical chemistry enzyme IVD, calibrator

Dimension® Flex® reagent cartridge MBI - 00842768025556

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

Dimension® CKI/MBI CAL - 00842768025549

CKI/MBI Calibrator, 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10464508
In Commercial Distribution

  • 00842768025549 ()
DC32

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

Dimension® Flex® reagent cartridge LIPL - 00842768025532

Lipase Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10460277
In Commercial Distribution

  • 00842768025532 ()
  • 00630414005454 ()
DF56

  • Lipase IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge CKI - 00842768025525

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

Dimension Vista® ECREA CAL - 00842768025419

Enzymatic Creatinine Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10464578
Not in Commercial Distribution

  • 00842768025419 ()
KC270

  • Creatinine IVD, calibrator

ADVIA Centaur® Zika Ab Quality Control - 00842768025273

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

Dimension® LIPL CAL - 00842768025228

Lipase Calibrator, 2x3x1mL
Siemens Healthcare Diagnostics Inc.
10460278
In Commercial Distribution

  • 00842768025228 ()
DC56

  • Lipase IVD, calibrator

Dimension Vista® System DRUG 3 CAL - 00842768025211

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

Dimension® CSA Flex® reagent cartridge - 00842768025136

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)

Dimension Vista® PNBP CAL - 00842768025129

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

Dimension Vista® Flex® reagent cartridge PBNP - 00842768025112

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
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