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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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ADVIA Chemistry P5PL_c Reagent - 00630414008950

ADVIA Chemistry Liquid P5P for use with ALTPLc and ASTPLc
Siemens Healthcare Diagnostics Inc.
10729782
In Commercial Distribution

  • 00630414306193 ()
  • 00630414008950 ()
10729782

  • Multiple clinical chemistry enzyme IVD, reagent

ADVIA Chemistry Creatine Kinase - 00630414008943

4 wedges per reagent , 2 reagent, 1100 test per carton
Siemens Healthcare Diagnostics Inc.
10729780
In Commercial Distribution

  • 00630414008943 ()
10729780

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry

Atellica IM 1300 Analyzer - 00630414007960

Atellica IM 1300 Analyzer
Siemens Healthcare Diagnostics Inc.
11066001
In Commercial Distribution

  • 00630414007960 ()
11066001

  • Chemiluminescent immunoassay analyser IVD

Atellica CH Li - 00630414006789

Lithium (Lith) Atellica CH - RGT 400T
Siemens Healthcare Diagnostics Inc.
11097535
Not in Commercial Distribution

  • 00630414006789 ()
11097535

  • Lithium therapeutic drug monitoring IVD, kit, atomic spectroscopy

Atellica IM TNIH MCM - 00630414006772

High Sensitivity Troponin I (TnIH) Atellica IM Master Curve Material Kit 5 X 1.0ml
Siemens Healthcare Diagnostics Inc.
10997842
In Commercial Distribution

  • 00630414006772 ()
10997842

  • Troponin I IVD, control

Atellica IM TNIH - 00630414006758

High Sensitivity Troponin I (TnIH) Atellica IM Assay Kit 500T
Siemens Healthcare Diagnostics Inc.
10997841
In Commercial Distribution

  • 00630414006758 ()
  • 00842768024559 ()
10997841

  • Troponin I IVD, kit, chemiluminescent immunoassay

Atellica IM TNIH - 00630414006703

High Sensitivity Troponin I (TnIH) Atellica IM Assay Kit 100T
Siemens Healthcare Diagnostics Inc.
10997840
In Commercial Distribution

  • 00630414006703 ()
10997840

  • Troponin I IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems Reaction Tubes - 00630414954547

Gear Driven Reaction Tubes 1000 - IMMULITE - CONS - 1000 Pieces
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385206
In Commercial Distribution

  • 00630414954547 ()
LRXT

  • General specimen container IVD, no additive/medium

Atellica CH Trig_2 - 00630414610955

Triglycerides_2 (Trig_2) Atellica CH Assay 2000 Tests
Siemens Healthcare Diagnostics Inc.
11537222
In Commercial Distribution

  • 00630414305110 ()
  • 00630414610955 ()
11537222

  • Triglyceride IVD, kit, spectrophotometry

Atellica CH LDLC CAL - 00630414610870

LDL Cholesterol Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11537241
In Commercial Distribution

  • 00630414305134 ()
  • 00630414610870 ()
11537241

  • Low density lipoprotein (LDL) cholesterol IVD, calibrator

Atellica CH HDLC CAL - 00630414610863

HDL Cholesterol Calibrator Atellica CH - CAL 3 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11537240
In Commercial Distribution

  • 00630414305165 ()
  • 00630414610863 ()
11537240

  • High density lipoprotein (HDL) cholesterol IVD, calibrator

Atellica CH Anti-Streptolysin-O_3 (ASO_3) - 00630414610856

Antistreptolysin O (ASO_3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537212
In Commercial Distribution

  • 00630414305097 ()
  • 00630414610856 ()
11537212

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

Atellica CH Iron3 (Iron3) - 00630414610849

Iron (Iron3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537211
In Commercial Distribution

  • 00630414305011 ()
  • 00630414610849 ()
11537211

  • Iron IVD, kit, spectrophotometry

Atellica CH HDLC - 00630414610832

HDL Cholesterol (HDLC) Atellica CH Assay 1792 Tests
Siemens Healthcare Diagnostics Inc.
11537213
In Commercial Distribution

  • 00630414305059 ()
  • 00630414610832 ()
11537213

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry

iCa++ Quick™ Sampler - 00630414609515

The iCa++ Quick™ Sampler is designed for in vitro diagnostic use with lithium heparin tubes, for the measurement of ionized Calcium(iCa++) on RAPIDPoint 500 systems and RAPIDLab 1260/1265 systems. This is suitable for professional use in a point-of-careor central laboratory environment.
Siemens Healthcare Diagnostics Inc.
11537817
In Commercial Distribution

  • 00630414609515 ()
11537817

  • Blood gas/haemoximetry analyser IVD, point-of-care

Clinitek Status Connector - 00630414607962

The CLINITEK Status Connector is intended for use with the CLINITEK Status+ analyzer.The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzerThe connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS)and interfaces with Electronic Medical Records (EMR).The CLINITEK Status Connector and CLINITEK Status+ analyzer together are the CLINITEK Status Connect system.
Siemens Healthcare Diagnostics Inc.
11537761
In Commercial Distribution

  • 00630414607962 ()
11537761

  • Urine analyser IVD, point-of-care

DV/DM COV2G/CV2G POS/NEG CTRL - 00630414607054

DV/DM COV2G/CV2G POS/NEG CTRL
Siemens Healthcare Diagnostics Inc.
11417773
Not in Commercial Distribution

  • 00630414298405 ()
  • 00630414607054 ()
KC873

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

DV/DM COV2G/CV2G CAL - 00630414607047

DV/DM COV2G/CV2G CAL
Siemens Healthcare Diagnostics Inc.
11417772
Not in Commercial Distribution

  • 00630414298399 ()
  • 00630414607047 ()
KC872

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

Atellica IM VB12 DIL - 00630414600291

Vitamin B12 (VB12) Diluent Atellica IM - CONS (2PK) 2 x 5mL
Siemens Healthcare Diagnostics Inc.
10995716
In Commercial Distribution

  • 00630414600291 ()
  • 00630414007908 ()
10995716

  • Buffered sample diluent IVD

Atellica IM VB12 - 00630414600284

Vitamin B12 (VB12) Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995715
In Commercial Distribution

  • 00630414600284 ()
  • 00630414007892 ()
10995715

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay

Atellica IM VB12 - 00630414600277

Vitamin B12 (VB12) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995714
In Commercial Distribution

  • 00630414600277 ()
10995714

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay

Atellica IM Tup - 00630414600253

T Uptake (Tup) Atellica IM - RGT 50T
Siemens Healthcare Diagnostics Inc.
10995712
In Commercial Distribution

  • 00630414600253 ()
10995712

  • Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay

Atellica IM Tup - 00630414600246

T Uptake (Tup) Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
10995711
In Commercial Distribution

  • 00630414600246 ()
  • 00630414007885 ()
10995711

  • Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay

Atellica IM TSTII MCM - 00630414600239

Testoterone II (TSTII) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995709
In Commercial Distribution

  • 00630414600239 ()
10995709

  • Total testosterone IVD, control

Atellica IM TSTII - 00630414600222

Testoterone II (TSTII) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995708
In Commercial Distribution

  • 00630414600222 ()
10995708

  • Total testosterone IVD, kit, chemiluminescent immunoassay

Atellica IM TSTII - 00630414600215

Testoterone II (TSTII) Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
10995707
In Commercial Distribution

  • 00630414600215 ()
10995707

  • Total testosterone IVD, kit, chemiluminescent immunoassay

Atellica IM TSH3-UL MCM - 00630414600185

TSH3-UL Atellica IM - Master Curve Material Kit 10 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995705
In Commercial Distribution

  • 00630414600185 ()
10995705

  • Thyroid stimulating hormone (TSH) IVD, control

Atellica IM TSH3-UL - 00630414600178

TSH3-UL Atellica IM - RGT 550T
Siemens Healthcare Diagnostics Inc.
10995704
In Commercial Distribution

  • 00630414600178 ()
10995704

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

Atellica IM TSH3-UL - 00630414600161

TSH3-UL Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995703
In Commercial Distribution

  • 00630414600161 ()
10995703

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

Atellica IM Toxo M QC - 00630414600154

Toxoplasma M IgM (ToxM) QC Kit Atellica IM - CLT 2 x 2 x 1.5mL
Siemens Healthcare Diagnostics Inc.
10995702
In Commercial Distribution

  • 00630414600154 ()
10995702

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control
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