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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 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

ADVIA® Chemistry Reagent Wedge 70 mL - 00630414601175

ADVIA Chemistry Reagent Wedge 70mL white
Siemens Healthcare Diagnostics Inc.
10487138
In Commercial Distribution

  • 00630414601175 ()
073-0373-03

  • Assay container IVD, single-use

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

ADVIA® Chemistry Reagent Wedge 20 mL - 00630414601052

ADVIA® Chemistry Reagent Wedge 20 mL
Siemens Healthcare Diagnostics Inc.
10487137
In Commercial Distribution

  • 00630414601052 ()
073-0372-03

  • Assay container IVD, single-use

Atellica™ IM aHBs2 MCM - 00630414600512

aHBs2 - Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995667
In Commercial Distribution

  • 00630414600512 ()
10995667

  • Hepatitis B virus surface total antibody IVD, control

Atellica IM PW3 - 00630414600505

Probe Wash 3 Atellica IM - CONS 1 x 50mL
Siemens Healthcare Diagnostics Inc.
10995666
In Commercial Distribution

  • 00630414600505 ()
10995666

  • Buffered wash solution IVD

Atellica IM IRI MCM - 00630414600482

Insulin (IRI) Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995632
In Commercial Distribution

  • 00630414600482 ()
10995632

  • Insulin IVD, control
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