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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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Control Plasma P - 00630414639703

Assayed control used to monitor the performance of coagulation assays in the pathological range
Siemens Healthcare Diagnostics Products GmbH
10873891
In Commercial Distribution

  • 00842768018589 ()
  • 00630414639703 ()
10873891

  • Multiple coagulation factor IVD, control

LA 2 Confirmation Reagent - 00630414639451

LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants
Siemens Healthcare Diagnostics Products GmbH
10873902
In Commercial Distribution

  • 00842768019661 ()
  • 00630414639451 ()
10873902

  • Lupus anticoagulant marker IVD, reagent

Atellica IM DHEAS2 MCM SET - 00630414632940

Atellica IM DHEASII MCM SET
Siemens Healthcare Diagnostics Inc.
11209195
In Commercial Distribution

  • 00630414632940 ()
11209195

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, control

Atellica IM DHEAS2 100T KIT - 00630414632926

Atellica IM DHEASII 100T KIT
Siemens Healthcare Diagnostics Inc.
11209193
In Commercial Distribution

  • 00630414632926 ()
11209193

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

ADVIA Centaur TSH3ULII MCM SET - 00630414624709

TSH3-ULII ADVIA Centaur - Consumable MCM Set
Siemens Healthcare Diagnostics Inc.
11208875
In Commercial Distribution

  • 00630414624709 ()
11208875

  • Thyroid stimulating hormone (TSH) IVD, control

Atellica IM TSH3-Ultra II - 00630414624693

TSH3-ULII Atellica IM - RGT (REF) 2750T
Siemens Healthcare Diagnostics Inc.
11208704
In Commercial Distribution

  • 00630414624693 ()
11208704

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Atellica IM TSH3ULII MCM set - 00630414624532

TSH3-ULII Atellica IM - Consumable MCM Set
Siemens Healthcare Diagnostics Inc.
11208876
In Commercial Distribution

  • 00630414624532 ()
11208876

  • Thyroid stimulating hormone (TSH) IVD, control

Atellica IM TSH3-Ultra II - 00630414624525

TSH3-ULII Atellica IM – RGT 550T
Siemens Healthcare Diagnostics Inc.
11208707
In Commercial Distribution

  • 00630414624525 ()
11208707

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Atellica IM TSH3-Ultra II - 00630414624518

TSH3-ULII Atellica IM - RGT 110T
Siemens Healthcare Diagnostics Inc.
11208706
In Commercial Distribution

  • 00630414624518 ()
11208706

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur TSH3-Ultra II - 00630414624501

TSH3-ULII ADVIA Centaur - RGT (REF) 2500T
Siemens Healthcare Diagnostics Inc.
11208703
In Commercial Distribution

  • 00630414624501 ()
11208703

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur TSH3-Ultra II - 00630414624488

TSH3-ULII ADVIA Centaur - RGT 500T
Siemens Healthcare Diagnostics Inc.
11208702
In Commercial Distribution

  • 00630414624488 ()
11208702

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

ATELLICA IM ELF KIT - 00630414618463

ATELLICA IM ELF KIT
Siemens Healthcare Diagnostics Inc.
11208118
In Commercial Distribution

  • 00630414618463 ()
11208118

  • Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay

ADVIA CENTAUR ELF KIT - 00630414618128

ADVIA CENTAUR ELF KIT
Siemens Healthcare Diagnostics Inc.
11207300
In Commercial Distribution

  • 00630414618128 ()
11207300

  • Multiple liver fibrosis marker IVD, kit, chemiluminescent immunoassay

ADVIA Centaur Androstenedione kit - 00630414603445

Androstenedione (Andro) ADVIA Centaur - RGT 50T
Siemens Healthcare Diagnostics Inc.
10997290
In Commercial Distribution

  • 00630414603445 ()
10997290

  • Androstenedione IVD, kit, chemiluminescent immunoassay

ADVIA Centaur Androstenedione MCM - 00630414603438

Androstenedione (Andro) ADVIA Centaur - Master Curve Material 5x1x1.0mL
Siemens Healthcare Diagnostics Inc.
10997268
In Commercial Distribution

  • 00630414603438 ()
10997268

  • Androstenedione IVD, control

ADVIA Centaur® SHBG MCM Set - 00630414603414

ADVIA Centaur Sex Hormone Binding Globulin Master Curve Material (SHBG MCM) Set - 5x1mL - 5 Levels
Siemens Healthcare Diagnostics Inc.
10997193
In Commercial Distribution

  • 00630414603414 ()
10997193

  • Sex hormone binding globulin (SHBG) IVD, control

ADVIA Centaur® CAL SHBG - 00630414603407

ADVIA Centaur Sex Hormone Binding Globulin Calibrator (SHBG CAL) Set - 2x2x2mL - 2PK
Siemens Healthcare Diagnostics Inc.
10997192
In Commercial Distribution

  • 00630414603407 ()
10997192

  • Sex hormone binding globulin (SHBG) IVD, calibrator

ADVIA Centaur® SHBG - 00630414603391

ADVIA Centaur Sex Hormone Binding Globulin (SHBG) - 50 tests - 1PK
Siemens Healthcare Diagnostics Inc.
10997191
In Commercial Distribution

  • 00630414603391 ()
10997191

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® Immunoassay Systems PRGE MCM - 00630414603070

Progesterone Master Curve Material SET - CENTAUR – CONS
Siemens Healthcare Diagnostics Inc.
10996673
In Commercial Distribution

  • 00630414603070 ()
10996673

  • Progesterone IVD, control

ADVIA Centaur® FSH MCM - 00630414603063

ADVIA Centaur FSH Master Curve Material (MCM) - 8x1mL - 8 levels
Siemens Healthcare Diagnostics Inc.
10996671
In Commercial Distribution

  • 00630414603063 ()
10996671

  • Follicle stimulating hormone (FSH) IVD, control

ADVIA® 560 Lyse - 00630414601878

ADVIA® 560 Lyse
Siemens Healthcare Diagnostics Inc.
11170846
In Commercial Distribution

  • 00630414601878 ()
D3015

  • Blood cell lysis reagent IVD

ADVIA® 360 Lyse 3P Diff - 00630414601281

ADVIA® 360 Lyse 3P Diff
Siemens Healthcare Diagnostics Inc.
11170848
In Commercial Distribution

  • 00630414601281 ()
D2011HK

  • Blood cell lysis reagent IVD

IMMULITE®/IMMULITE® 1000 Systems IGF-I - 00630414601243

Insulin-like growth factor I (IGF-I) 100 test kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128584
In Commercial Distribution

  • 00630414601243 ()
LKIGF1

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems IGF-I - 00630414601236

Insulin-like growth factor I (IGF-I) 200 test kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128543
In Commercial Distribution

  • 00630414601236 ()
L2KIGF2

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay

Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 4 - 00630414601168

Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 4
Siemens Healthcare Diagnostics Inc.
10720052
In Commercial Distribution

  • 00630414601168 ()
9S589UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 3 - 00630414601151

Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 3
Siemens Healthcare Diagnostics Inc.
10720051
In Commercial Distribution

  • 00630414601151 ()
9S569UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 2 - 00630414601144

Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 2
Siemens Healthcare Diagnostics Inc.
10720050
In Commercial Distribution

  • 00630414601144 ()
9S549UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® II Plus Specialty Drug Calibrator/Control Level 1 - 00630414601137

Syva® Emit® II Plus Buprenorphine Calibrator and Control, Level 1
Siemens Healthcare Diagnostics Inc.
10720049
In Commercial Distribution

  • 00630414601137 ()
9S529UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® II Plus Specialty Drug Control Positive - 00630414601090

Syva® Emit® II Plus Buprenorphine Control Positive
Siemens Healthcare Diagnostics Inc.
10718701
In Commercial Distribution

  • 00630414601090 ()
9S619UL

  • Multiple drugs of abuse IVD, control

Syva® Emit® II Plus Specialty Drug Control Negative - 00630414601083

Syva® Emit® II Plus Buprenorphine Control Negative
Siemens Healthcare Diagnostics Inc.
10718700
In Commercial Distribution

  • 00630414601083 ()
9S609UL

  • Multiple drugs of abuse IVD, control
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