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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Quality control for CLINITEK Atlas® and CLINITEK Novus® analyzers
Siemens Healthcare Diagnostics Inc.
10311124
In Commercial Distribution

  • 00630414373201 ()
  • 00630414009315 ()
5019

  • Multiple urine analyte IVD, control
Clinitek Atlas® Calibration Kit. For use with CLINITEK ATLAS® Automated Urine Chemistry System.
Siemens Healthcare Diagnostics Inc.
10311123
In Commercial Distribution

  • 00630414373027 ()
5018A

  • Multiple urine analyte IVD, control
Clinitek Atlas® 10 Reagent PAK for Urine Chemistry for use with the Clinitek Atlas® Urine Chemistry Analyzer
Siemens Healthcare Diagnostics Inc.
10311120
In Commercial Distribution

  • 00630414373003 ()
5017

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Rinse additive, an in vitro diagnostics device for use on the CLINITEK Atlas® automated urine chemistry system
Siemens Healthcare Diagnostics Inc.
10311113
In Commercial Distribution

  • 00630414372464 ()
  • 00630414009308 ()
5007A

  • Buffered wash solution IVD
Clinitek Atlas® Calibrator #4 In vitro diagnostic medical device
Siemens Healthcare Diagnostics Inc.
10311106
In Commercial Distribution

  • 00630414372181 ()
5006

  • Multiple urine analyte IVD, control
Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination
Siemens Healthcare Diagnostics Products GmbH
10874080
In Commercial Distribution

  • 00842768018800 ()
  • 00630414320366 ()
10874080

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent
No Description
Siemens Healthcare Diagnostics Inc.
11697146
In Commercial Distribution

  • 00630414317496 ()
11697146

  • Medical equipment clinical data interfacing software
No Description
Siemens Healthcare Diagnostics Inc.
11697145
In Commercial Distribution

  • 00630414317489 ()
11697145

  • Medical equipment clinical data interfacing software
No Description
Siemens Healthcare Diagnostics Inc.
11697144
In Commercial Distribution

  • 00630414317472 ()
11697144

  • Medical equipment clinical data interfacing software
HA1C_E HIGH VOLUME CONVERSION KIT ATELLICA CH
Siemens Healthcare Diagnostics Inc.
11470732
In Commercial Distribution

  • 00630414306179 ()
11470732

  • Instrument/analyser specimen/reagent container carrier IVD
Atellica IM Ancillary Seal Kit
Siemens Healthcare Diagnostics Inc.
11208742
In Commercial Distribution

  • 00630414306032 ()
11208742

  • Assay container liner IVD
Atellica CI 1900 Dilution Cuvette
Siemens Healthcare Diagnostics Inc.
11099501
In Commercial Distribution

  • 00630414304526 ()
11099501

  • Laboratory analyser cuvette IVD, reusable
Atellica CI 1900 Reaction Cuvette
Siemens Healthcare Diagnostics Inc.
11099500
In Commercial Distribution

  • 00630414304519 ()
11099500

  • Laboratory analyser cuvette IVD, reusable
ATELLICA CH LID KEYING FEATURE KIT
Siemens Healthcare Diagnostics Inc.
11597266
In Commercial Distribution

  • 00630414304328 ()
11597266

  • Instrument/analyser test tube rack cover IVD
HA1C_E HIGH VOLUME LABEL KIT ATELLICA CH (50 LABELS)
Siemens Healthcare Diagnostics Inc.
11597090
In Commercial Distribution

  • 00630414304311 ()
11597090

  • Printer label IVD
HA1C_E HIGH VOLUME BOTTLE KIT ATELLICA CH (5 BOTTLES)
Siemens Healthcare Diagnostics Inc.
11597087
In Commercial Distribution

  • 00630414304304 ()
11597087

  • Assay container IVD, reusable
Atellica IM aHCV 200T Kit
Siemens Healthcare Diagnostics Inc.
11207260
In Commercial Distribution

  • 00630414301341 ()
11207260

  • Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
Vitamin D total 25(OH) (VitD) QC Kit Atellica IM - CLT 2 x 3 x 2.0mL
Siemens Healthcare Diagnostics Inc.
11207292
In Commercial Distribution

  • 00630414301334 ()
11207292

  • Multiple form 25-hydroxy Vitamin D IVD, control
HBsAgII (HBsII) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207286
In Commercial Distribution

  • 00630414301327 ()
11207286

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Hepatitis Be Antigen (HBeAg) - Atellica IM - RGT - 50T
Siemens Healthcare Diagnostics Inc.
11207281
In Commercial Distribution

  • 00630414301310 ()
11207281

  • Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay
HBC Total Ab (HBcT) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207276
In Commercial Distribution

  • 00630414301303 ()
11207276

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
HAV Total Ab (aHAVT) Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207271
In Commercial Distribution

  • 00630414301297 ()
11207271

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
CHIV - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207266
In Commercial Distribution

  • 00630414301280 ()
11207266

  • HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay
Anti-HBs2 (aHBs2) - Atellica IM - RGT - 200T
Siemens Healthcare Diagnostics Inc.
11207255
In Commercial Distribution

  • 00630414301273 ()
11207255

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
HBc IgM (aHBcM) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
11207249
In Commercial Distribution

  • 00630414301266 ()
11207249

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
HAV IgM Ab (aHAVM) - Atellica IM - RGT 100T
Siemens Healthcare Diagnostics Inc.
11207243
In Commercial Distribution

  • 00630414301259 ()
11207243

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
TSH3-UL - Atellica IM - RGT 2750T
Siemens Healthcare Diagnostics Inc.
11206262
In Commercial Distribution

  • 00630414293875 ()
11206262

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Sex Hormone Binding Globulin (SHBG) - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206312
In Commercial Distribution

  • 00630414294285 ()
  • 00630414293868 ()
11206312

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
Free T4 (FT4) - Atellica IM - RGT 1250T
Siemens Healthcare Diagnostics Inc.
11206313
In Commercial Distribution

  • 00630414294292 ()
  • 00630414293851 ()
11206313

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay
DHEAS - Atellica IM - RGT 250T
Siemens Healthcare Diagnostics Inc.
11206311
In Commercial Distribution

  • 00630414293844 ()
11206311

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Vitamin D total 25(OH) (VitD) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206265
In Commercial Distribution

  • 00630414293837 ()
11206265

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
Vitamin B12 (VB12) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206264
In Commercial Distribution

  • 00630414294261 ()
  • 00630414293820 ()
11206264

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Testoterone II (TSTII) - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206263
In Commercial Distribution

  • 00630414293813 ()
11206263

  • Total testosterone IVD, kit, chemiluminescent immunoassay
TSH3-UL - Atellica IM - RGT 550T
Siemens Healthcare Diagnostics Inc.
11206304
In Commercial Distribution

  • 00630414293806 ()
11206304

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TnI-Ultra - Atellica IM - RGT 500T
Siemens Healthcare Diagnostics Inc.
11206219
In Commercial Distribution

  • 00630414293790 ()
11206219

  • Troponin I IVD, kit, chemiluminescent immunoassay
MTO PROTECTION STATION KIT-EVANSTON HOSP
MEDLINE INDUSTRIES, INC.
60050078
In Commercial Distribution

  • 20193489043225 ()
  • 10193489043228 ()
60050078

  • Angiography kit
MTS MITRAL VALVE KIT - EVANSTON HOSP
MEDLINE INDUSTRIES, INC.
60050074
In Commercial Distribution

  • 20193489043218 ()
  • 10193489043211 ()
60050074

  • Angiography kit
MTO NEURO KIT 2
MEDLINE INDUSTRIES, INC.
60050034
In Commercial Distribution

  • 20193489043201 ()
  • 10193489043204 ()
60050034

  • Angiography kit
MTO NEURO KIT 1
MEDLINE INDUSTRIES, INC.
60050033
In Commercial Distribution

  • 20193489043195 ()
  • 10193489043198 ()
60050033

  • Angiography kit
MTO RIGHT HEART KIT-ELLIS HOSP
MEDLINE INDUSTRIES, INC.
60050013
In Commercial Distribution

  • 20193489043188 ()
  • 10193489043181 ()
60050013

  • Angiography kit
MTS LEFT HEART KIT DIAGNOSTIC HEART CEN
MEDLINE INDUSTRIES, INC.
60042721
In Commercial Distribution

  • 20193489043171 ()
  • 10193489043174 ()
60042721

  • Angiography kit
MTO 3V KIT CORONARY WOMENS HOSP-RENAIS
MEDLINE INDUSTRIES, INC.
60042454
In Commercial Distribution

  • 20193489043164 ()
  • 10193489043167 ()
60042454

  • Angiography kit
MTS 2V KIT-WOMENS HOSP. RENAISS - PG
MEDLINE INDUSTRIES, INC.
60042453
In Commercial Distribution

  • 20193489043157 ()
  • 10193489043150 ()
60042453

  • Angiography kit
MTO 3VALVE PERC MANIFOLD KIT DESERT VAL
MEDLINE INDUSTRIES, INC.
60042402
In Commercial Distribution

  • 20193489043140 ()
  • 10193489043143 ()
60042402

  • Angiography kit
MTO LEFT HEART KIT SE OKLAHOMA
MEDLINE INDUSTRIES, INC.
60042301
In Commercial Distribution

  • 20193489043133 ()
  • 10193489043136 ()
60042301

  • Angiography kit
MTS RHK DEPT OF VETERANS AFFAIRS
MEDLINE INDUSTRIES, INC.
60042271
In Commercial Distribution

  • 20193489043126 ()
  • 10193489043129 ()
60042271

  • Angiography kit
MTO LEFT HEART KIT-DELTA
MEDLINE INDUSTRIES, INC.
60042001
In Commercial Distribution

  • 20193489043119 ()
  • 10193489043112 ()
60042001

  • Angiography kit
MTO LEFT HEART KIT DEARBORN COUNTY HOSP
MEDLINE INDUSTRIES, INC.
60041942
In Commercial Distribution

  • 20193489043102 ()
  • 10193489043105 ()
60041942

  • Angiography kit
MTO PERIPHERAL KIT-DOCTORS HOSPITAL
MEDLINE INDUSTRIES, INC.
60041745
In Commercial Distribution

  • 20193489043096 ()
  • 10193489043099 ()
60041745

  • Angiography kit
MTO RT HRT KIT-DOCTORS HOSP
MEDLINE INDUSTRIES, INC.
60041744
In Commercial Distribution

  • 20193489043089 ()
  • 10193489043082 ()
60041744

  • Angiography kit
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