SEARCH RESULTS FOR: siemens(7236 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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N Protein Standard UY - 00630414167848

Calibration of Human a1-microglobulin and cystatin C assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873632
In Commercial Distribution

  • 00630414167848 ()
  • 00842768018978 ()
10873632

  • Plasma protein IVD, calibrator

N Latex Cystatin C - 00630414167824

Quantitative determination of cystatin C in human serum and lithium-heparinized plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873631
In Commercial Distribution

  • 00630414167824 ()
OQNM19

  • Cystatin C IVD, kit, nephelometry/turbidimetry

IMMULITE 2000 Progesterone Kit Domestic 200T - 00630414167718

IMMULITE 2000 Progesterone Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901873
In Commercial Distribution

  • 00630414167718 ()
L2KPW2(D)

  • Progesterone IVD, kit, chemiluminescent immunoassay

N LATEX FLC lambda - 00630414167664

Quantitative determination of free light chains (FLC) type lambda in human serum and EDTA-plasma on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10873630
In Commercial Distribution

  • 00630414167664 ()
  • 00630414229089 ()
OPJB07

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

N LATEX FLC KAPPA - 00630414167657

Quantitative determination of free light chains (FLC) type kappa in human serum and EDTA-plasma on Siemens analyzers
Siemens Healthcare Diagnostics Products GmbH
10873629
In Commercial Distribution

  • 00630414167657 ()
  • 00630414229072 ()
OPJA075

  • Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetry

IMMULITE 2000 Progesterone Kit Domestic 600T - 00630414167510

IMMULITE 2000 Progesterone Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901874
In Commercial Distribution

  • 00630414167510 ()
L2KPW6(D)

  • Progesterone IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 Prolactin Kit Domestic 600T - 00630414167503

IMMULITE 2000 Prolactin Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901869
In Commercial Distribution

  • 00630414167503 ()
L2KPR6(D)

  • Prolactin IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 Prolactin Kit Domestic 200T - 00630414167497

IMMULITE 2000 Prolactin Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901868
In Commercial Distribution

  • 00630414167497 ()
L2KPR2(D)

  • Prolactin IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 LH Kt Domestic 600T - 00630414167480

IMMULITE 2000 LH Kt Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901864
In Commercial Distribution

  • 00630414167480 ()
L2KLH6(D)

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 LH Kit Domestic 200T - 00630414167459

IMMULITE 2000 LH Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901863
In Commercial Distribution

  • 00630414167459 ()
L2KLH2(D)

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 FSH Kit Domestic 600T - 00630414167442

IMMULITE 2000 FSH Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901859
In Commercial Distribution

  • 00630414167442 ()
L2KFS6(D)

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 FSH Kit Domestic 200T - 00630414167435

IMMULITE 2000 FSH Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901852
In Commercial Distribution

  • 00630414167435 ()
L2KFS2(D)

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 DHEAS Kit Domestic 200T - 00630414167428

IMMULITE 2000 DHEAS Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901849
In Commercial Distribution

  • 00630414167428 ()
L2KDS2(D)

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 Crotisol Kit Domestic 600T - 00630414167411

IMMULITE 2000 Crotisol Kit Domestic 600T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901845
In Commercial Distribution

  • 00630414167411 ()
L2KCO6(D)

  • Total cortisol IVD, kit, chemiluminescent immunoassay

IMMULITE 2000 Cortisol Kit Domestic 200T - 00630414167404

IMMULITE 2000 Cortisol Kit Domestic 200T
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10901844
In Commercial Distribution

  • 00630414167404 ()
L2KCO2(D)

  • Total cortisol IVD, kit, chemiluminescent immunoassay

Dade® Fibrinogen Determination Reagents - 00630414023526

Quantitative determination of fibrinogen in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873571
In Commercial Distribution

  • 00630414023526 ()
B4233-17SY

  • Fibrinogen assay (factor I) IVD, kit, clotting

LA Control High - 00630414023519

LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873570
In Commercial Distribution

  • 00630414023519 ()
  • 00842768019685 ()
OQWD13

  • Lupus anticoagulant marker IVD, control

LA Control Low - 00630414023502

LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
Siemens Healthcare Diagnostics Products GmbH
10873569
In Commercial Distribution

  • 00630414023502 ()
  • 00842768019678 ()
OQWE13

  • Lupus anticoagulant marker IVD, control

Dade® Innovin® - 00630414023496

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873568
In Commercial Distribution

  • 00630414023496 ()
  • 00842768019609 ()
B4212-101

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00630414023489

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873567
In Commercial Distribution

  • 00630414023489 ()
  • 00842768019586 ()
B4212-51

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00630414023472

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10873566
In Commercial Distribution

  • 00630414023472 ()
  • 00842768019593 ()
B4212-41

  • Prothrombin time (PT) IVD, reagent

Thromborel® S - 00630414023465

Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873565
In Commercial Distribution

  • 00630414023465 ()
  • 00842768018749 ()
OUHP53

  • Prothrombin time (PT) IVD, reagent

Thromborel® S - 00630414023441

Determination of prothrombin time (PT) and of the activity of coagulation factors II, V, VII and X
Siemens Healthcare Diagnostics Products GmbH
10873564
Not in Commercial Distribution

  • 00630414023441 ()
  • 00842768018756 ()
OUHP31

  • Prothrombin time (PT) IVD, kit, clotting

IMMULITE® 2000 TSI CVM - 00630414006680

IMMULITE(R) 2000 TSI CVM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10715502
In Commercial Distribution

  • 00630414006680 ()
L2SICVM

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control

IMMULITE 2000 rPru av 1 Specific Allergen - 00630414006345

rPru av 1 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471072
In Commercial Distribution

  • 00630414006345 ()
A597L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE 2000 rMal d 4 Specific Allergen - 00630414006291

rMal d 4 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471077
In Commercial Distribution

  • 00630414006291 ()
A796L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE 2000 nPru p 3 Specific Allergen - 00630414006284

nPru p 3 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10368596
In Commercial Distribution

  • 00630414006284 ()
A603L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE 2000 rPru av 4 Specific Allergen - 00630414006277

rPru av 4 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471075
In Commercial Distribution

  • 00630414006277 ()
A600L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE 2000 rPru av 3 Specific Allergen - 00630414006253

rPru av 3 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471074
In Commercial Distribution

  • 00630414006253 ()
A599L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE 2000 rMal d 1 Specific Allergen - 00630414006246

rMal d 1 Allergen
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10483381
In Commercial Distribution

  • 00630414006246 ()
A464L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

BN II System - 00630414002903

The BN II is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
Siemens Healthcare Diagnostics Products GmbH
11254820
In Commercial Distribution

  • 00630414002903 ()
OVIA112

  • Nephelometry immunoassay analyser IVD

BN ProSpec® System - 00630414002736

The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
Siemens Healthcare Diagnostics Products GmbH
10465217
In Commercial Distribution

  • 00630414002736 ()
OVLI012

  • Nephelometry immunoassay analyser IVD

IMMULITE® GROWTH HORMONE CVM - 00630414000213

Growth Hormone CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128533
In Commercial Distribution

  • 00630414000213 ()
LGRHCVM

  • Human growth hormone (HGH) IVD, control

IMMULITE 2000 Systems Anti-CCP IgG Calibration Verification Material - 00630414000206

IMMULITE® 2000 Systems CCP Calibration Verification Material Anti-CCP IgG
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10718363
In Commercial Distribution

  • 00630414000206 ()
L2PICVM(D)

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control

IMMULITE 2000 rBet v 2 Specific Allergen - 00630414000138

rBet v 2 Alleren
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10484690
In Commercial Distribution

  • 00630414000138 ()
A127L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE® 2000 Systems Herpes I and II IgG - 00630414999784

IMMULITE® 2000 Systems Herpes I and II IgG
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381333
In Commercial Distribution

  • 00630414999784 ()
L2KHVG6

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

IMMULITE® INS Control Insulin - 00630414998954

Insulin Module - IMMULITE - CTL - 2x5mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10286614
In Commercial Distribution

  • 00630414998954 ()
LINCM

  • Insulin IVD, control

IMMULITE® SBG Control SHBG - 00630414998947

SHBG - IMMULITE - CTL - 1x1x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10285226
In Commercial Distribution

  • 00630414998947 ()
LSHCM

  • Sex hormone binding globulin (SHBG) IVD, control

IMMULITE® 2000 Systems UE3 Unconjugated Estriol - 00630414997162

Estriol unconjugated - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381192
In Commercial Distribution

  • 00630414997162 ()
L2KUE32

  • Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems F4 Free T4 - 00630414996868

Free T4 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381622
In Commercial Distribution

  • 00630414996868 ()
LKFT41

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
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