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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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Syva® Emit® II Plus Buprenorphine Assay - 00630414601120

Syva® Emit® II Plus Buprenorphine Assay – 28 mL kit
Siemens Healthcare Diagnostics Inc.
10720048
In Commercial Distribution

  • 00630414601120 ()
9S039UL

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Buprenorphine Assay - 00630414601113

Syva® Emit® II Plus Buprenorphine Assay - 115 mL kit
Siemens Healthcare Diagnostics Inc.
10720047
In Commercial Distribution

  • 00630414601113 ()
9S029UL

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Buprenorphine Assay - 00630414601106

Syva® Emit® II Plus Buprenorphine Assay - 1L kit
Siemens Healthcare Diagnostics Inc.
10720046
In Commercial Distribution

  • 00630414601106 ()
9S129UL

  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)

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

ADVIA® 560 Control - 00630414600840

ADVIA® 560 Control
Siemens Healthcare Diagnostics Inc.
11170854
In Commercial Distribution

  • 00630414600840 ()
11170854

  • Full blood count IVD, control

ADVIA® 360 Control - 00630414600833

ADVIA®360 Control
Siemens Healthcare Diagnostics Inc.
11170853
In Commercial Distribution

  • 00630414600833 ()
11170853

  • Full blood count IVD, control

ADVIA® 360/560 Calibrator - 00630414600826

No Description
Siemens Healthcare Diagnostics Inc.
11170852
In Commercial Distribution

  • 00630414600826 ()
11170852

  • Full blood count IVD, calibrator

ADVIA® Chemistry Alkaline Phosphatase (ALP_2c) Reagents - 00630414600611

Alkaline Phosphatase - ADVIA Chem. - Conc. RGT - 6x1240
Siemens Healthcare Diagnostics Inc.
10916067
In Commercial Distribution

  • 00630414600611 ()
  • 00630414006178 ()
10916067

  • Alanine aminotransferase (ALT) IVD, reagent

Atellica IM Rub G QC - 00630414600536

Rubella IgG (Rub G) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL
Siemens Healthcare Diagnostics Inc.
10995671
In Commercial Distribution

  • 00630414600536 ()
10995671

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

Atellica IM Rub G - 00630414600529

Rubella IgG (Rub G) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995670
In Commercial Distribution

  • 00630414600529 ()
10995670

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

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

Atellica IM IRI DIL - 00630414600475

Insulin (IRI) Diluent Bottle Atellica IM - CONS) 1 x 10mL
Siemens Healthcare Diagnostics Inc.
10995631
In Commercial Distribution

  • 00630414600475 ()
10995631

  • Buffered sample diluent IVD

Atellica IM IRI DIL - 00630414600468

Insulin (IRI) Diluent Atellica IM - CONS (2PK) 2 x 10mL
Siemens Healthcare Diagnostics Inc.
10995630
In Commercial Distribution

  • 00630414600468 ()
  • 00630414007953 ()
10995630

  • Buffered sample diluent IVD

Atellica IM IRI Calibrator - 00630414600451

Insulin (IRI) Calibrator Atellica IM - CAL (2PK) 2 x 2 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995629
In Commercial Distribution

  • 00630414600451 ()
  • 00842768027406 ()
10995629

  • Insulin IVD, calibrator

Atellica IM IRI - 00630414600444

Insulin (IRI) Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
10995628
In Commercial Distribution

  • 00630414600444 ()
10995628

  • Insulin IVD, kit, chemiluminescent immunoassay

Atellica IM CpS MCM - 00630414600437

C-Peptide (CpS) Atellica IM - Master Curve Material Kit 10 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995543
In Commercial Distribution

  • 00630414600437 ()
10995543

  • C-peptide IVD, control
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