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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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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
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