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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 ENZ 1 Calibrator - 00630414597225

Enzyme 1 (ENZ 1) Calibrator Atellica CH - CAL 6 x 2.5mL
Siemens Healthcare Diagnostics Inc.
11099317
In Commercial Distribution

  • 00630414597225 ()
  • 00630414007014 ()
11099317

  • Multiple clinical chemistry enzyme IVD, calibrator

Atellica CH ALP_2 Calibrator - 00630414597218

Alkaline Phosphatase Calibrator (ALP) Atellica CH - CAL 6 x 1.0mL
Siemens Healthcare Diagnostics Inc.
11099316
In Commercial Distribution

  • 00630414597218 ()
  • 00630414007045 ()
11099316

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Atellica CH AlbP Calibrator - 00630414597201

Albumin BCP (AlbP) Calibrator Atellica CH - CAL 3 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11099310
In Commercial Distribution

  • 00630414597201 ()
  • 00630414007052 ()
11099310

  • Albumin IVD, calibrator

IMMULITE® 2000 TSI - 00630414597188

IMMULITE(R) 2000 TSI Assay
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10876421
In Commercial Distribution

  • 00630414597188 ()
L2KSI2(D)

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® XPT Analyzer - 00630414596914

ADVIA Centaur® XPT Analyzer
Siemens Healthcare Diagnostics Inc.
10711433
In Commercial Distribution

  • 00630414596914 ()
10711433

  • Chemiluminescent immunoassay analyser IVD

AptioTM Automation - 00630414596754

APTIO INPUT/OUTPUT MODULE W/O SLOT
Siemens Healthcare Diagnostics Inc.
10713760
In Commercial Distribution

  • 00630414596754 ()
APT-201-01

  • Specimen processing instrument IVD

Hematek® 3000 System - 00630414596563

The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro diagnostic use in the clinical laboratoy
Siemens Healthcare Diagnostics Products GmbH
10805311
In Commercial Distribution

  • 00630414596563 ()
10805311

  • Microscope slide stainer IVD

Atellica CH CHK - 00630414596556

Check ReagentT Fluid (CHK) Atellica CH - CONS 4 X 47mL/4 X 47mL
Siemens Healthcare Diagnostics Inc.
11099311
In Commercial Distribution

  • 00630414596556 ()
  • 00630414211503 ()
11099311

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use

Atellica CH RPC1 - 00630414596549

Reagent Probe Cleaner 1 (RPC1) Atellica CH - CONS 4 X 44.6mL/4 X 44.6mL
Siemens Healthcare Diagnostics Inc.
11099312
In Commercial Distribution

  • 00630414596549 ()
  • 00630414211510 ()
11099312

  • Wash/cleaning solution IVD, automated/semi-automated system

Atellica CH RPC2 - 00630414596532

Reagent Probe Cleaner 2 (RPC2) Atellica CH - CONS 4 X 44.6mL/4 X 44.6mL
Siemens Healthcare Diagnostics Inc.
11099313
In Commercial Distribution

  • 00630414596532 ()
  • 00630414211527 ()
11099313

  • Wash/cleaning solution IVD, automated/semi-automated system
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