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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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IMMULITE®/IMMULITE® 1000 Systems ALB Albumin Sample Diluent - 00630414953526

Albumin Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387031
In Commercial Distribution

  • 00630414953526 ()
LHAZ

  • Buffered sample diluent IVD

IMMULITE®/IMMULITE®1000 Systems AF AFP Sample Diluent - 00630414953519

AF AFP Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387015
In Commercial Distribution

  • 00630414953519 ()
LAPZ

  • Buffered sample diluent IVD

IMMULITE®/IMMULITE® 1000 Systems ACT ACTH Sample Diluent - 00630414953502

ACTH Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387014
In Commercial Distribution

  • 00630414953502 ()
LACZ

  • Buffered sample diluent IVD

IMMULITE® 2000 Systems SPE 3gAllergy Specific IgE Sample Diluent - 00630414953496

3G Allergy Sample Diluent - IMMULITE - CAL - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10283033
In Commercial Distribution

  • 00630414953496 ()
L2UNZ

  • Buffered sample diluent IVD

IMMULITE® Systems TIE CONTROL Total IgE - 00630414953458

IgE total - IMMULITE - CTL - 2x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385349
In Commercial Distribution

  • 00630414953458 ()
IECM

  • Total immunoglobulin E (IgE total) IVD, control

Dade Hepzyme - 00630414640396

Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing
Siemens Healthcare Diagnostics Products GmbH
10873841
In Commercial Distribution

  • 00842768019487 ()
  • 00630414640396 ()
10873841

  • Coagulation inhibitory substance neutralization IVD, reagent

Factor VIII Chromogenic Assay - 00630414640389

Determination of Factor VIII (antihemophilic factor) activity in human plasma
Siemens Healthcare Diagnostics Products GmbH
10873840
In Commercial Distribution

  • 00630414640389 ()
10873840

  • Coagulation factor VIII IVD, kit, chromogenic

Dade Thrombin Reagent - 00630414640372

Determination of fibrinogen in plasma and to accelerate coagulation of anticoagulated samples for immunohematology studies
Siemens Healthcare Diagnostics Products GmbH
10873838
In Commercial Distribution

  • 00842768019500 ()
  • 00630414640372 ()
10873838

  • Fibrinogen assay (factor I) IVD, reagent

Dade Actin FSL Activated PTT Reagent - 00630414640358

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873832
In Commercial Distribution

  • 00842768019555 ()
  • 00630414640358 ()
10873832

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade Actin FS Activated PTT Reagent - 00630414640341

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10873830
In Commercial Distribution

  • 00842768019562 ()
  • 00630414640341 ()
10873830

  • Activated partial thromboplastin time (APTT) IVD, reagent
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