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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Alinity i STAT Myoglobin Calibrators
Abbott Ireland Diagnostics
04V3701
In Commercial Distribution

  • 00380740172275 ()
04V3701

  • Myoglobin IVD, calibrator
Alinity i STAT CK-MB Controls
Abbott Ireland Diagnostics
04V3810
In Commercial Distribution

  • 00380740165505 ()
04V3810

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, control
Alinity i STAT CK-MB Calibrators
Abbott Ireland Diagnostics
04V3801
In Commercial Distribution

  • 00380740165482 ()
04V3801

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
Alinity i B_hCG Assay File
Abbott GmbH
07P515A
In Commercial Distribution

  • 00380740160807 ()
07P515A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-20
Not in Commercial Distribution

  • 00380740159412 ()
04P5520

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-19
Not in Commercial Distribution

  • 00380740157050 ()
04P5519

  • Laboratory instrument/analyser application software IVD
Alinity i Maintenance Cleaning Cartridge
ABBOTT LABORATORIES
02R5250
In Commercial Distribution

  • 00380740156824 ()
  • 00380740167769 ()
02R5250

  • Multiple clinical chemistry analyser IVD, laboratory
Alinity i tHCY-DIL Assay File
Abbott GmbH
09P283A
In Commercial Distribution

  • 00380740155797 ()
09P283A

  • Laboratory instrument/analyser application software IVD
Alinity I Intact PTH Controls
Abbott GmbH
08P3111
In Commercial Distribution

  • 00380740155377 ()
08P3111

  • Parathyroid hormone (PTH) IVD, control
Alinity i BRAHMS PCT Controls
Abbott Ireland Diagnostics
01R1810
In Commercial Distribution

  • 00380740153946 ()
01R1810

  • Procalcitonin (PCT) IVD, control
Alinity i BRAHMS PCT Calibrators
Abbott Ireland Diagnostics
01R1801
In Commercial Distribution

  • 00380740153939 ()
01R1801

  • Procalcitonin (PCT) IVD, calibrator
Alinity i Tacrolimus Assay File
Abbott GmbH
09P421A
In Commercial Distribution

  • 00380740151751 ()
09P421A

  • Laboratory instrument/analyser application software IVD
Alinity i SHBG Assay File
Abbott GmbH
09P381A
In Commercial Distribution

  • 00380740151737 ()
09P381A

  • Laboratory instrument/analyser application software IVD
Alinity i PCT Assay File
Abbott GmbH
01R181A
In Commercial Distribution

  • 00380740151690 ()
01R181A

  • Laboratory instrument/analyser application software IVD
Alinity i Insulin Assay File
Abbott GmbH
04T751A
In Commercial Distribution

  • 00380740151614 ()
04T751A

  • Laboratory instrument/analyser application software IVD
Alinity i FSH Assay File
Abbott GmbH
07P491A
In Commercial Distribution

  • 00380740151553 ()
07P491A

  • Laboratory instrument/analyser application software IVD
Alinity i C-Peptide Assay File
Abbott GmbH
09P361A
In Commercial Distribution

  • 00380740151485 ()
09P361A

  • Laboratory instrument/analyser application software IVD
Alinity i A-HBsDilUS Assay File
Abbott GmbH
07P883A
In Commercial Distribution

  • 00380740151461 ()
07P883A

  • Laboratory instrument/analyser application software IVD
Alinity i VitB12 Assay File
Abbott GmbH
07P673A
In Commercial Distribution

  • 00380740151447 ()
07P673A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-Tg Assay File
Abbott GmbH
09P341A
In Commercial Distribution

  • 00380740151423 ()
09P341A

  • Laboratory instrument/analyser application software IVD
Alinity i Active-B12 (Holotranscobalamin) Controls
Abbott GmbH
09P2610
In Commercial Distribution

  • 00380740150518 ()
09P2610

  • Vitamin B12 IVD, control
Alinity i Anti-HBs Specimen Diluent
Abbott Ireland Diagnostics
07P8841
In Commercial Distribution

  • 00380740149598 ()
07P8841

  • Buffered sample diluent IVD
Alinity i POSTM_ROMA Assay File
Abbott GmbH
03R753A
In Commercial Distribution

  • 00380740146634 ()
03R753A

  • Laboratory instrument/analyser application software IVD
Alinity i PREM_ROMA Assay File
Abbott GmbH
03R751A
In Commercial Distribution

  • 00380740146627 ()
03R751A

  • Laboratory instrument/analyser application software IVD
Alinity i CA19-9XR Assay File
Abbott GmbH
08P321A
In Commercial Distribution

  • 00380740146580 ()
08P321A

  • Laboratory instrument/analyser application software IVD
Alinity i Cortisol Assay File
Abbott GmbH
08P331A
In Commercial Distribution

  • 00380740146436 ()
08P331A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-HBc IgM Calibrators
Abbott GmbH
07P8602
In Commercial Distribution

  • 00380740146177 ()
07P8602

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibrator
Alinity i Anti-HBc IgM Controls
Abbott GmbH
07P8612
In Commercial Distribution

  • 00380740145187 ()
07P8612

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
Alinity i CEA Assay File
Abbott GmbH
07P621A
In Commercial Distribution

  • 00380740142889 ()
07P621A

  • Laboratory instrument/analyser application software IVD
Alinity i Ferritin Assay File
Abbott GmbH
07P651A
In Commercial Distribution

  • 00380740142834 ()
07P651A

  • Laboratory instrument/analyser application software IVD
Alinity i T-Uptake Assay File
Abbott GmbH
08P121A
In Commercial Distribution

  • 00380740142810 ()
08P121A

  • Laboratory instrument/analyser application software IVD
Alinity i Anti-HCV Assay File
Abbott GmbH
08P051B
In Commercial Distribution

  • 00380740142155 ()
08P051B

  • Laboratory instrument/analyser application software IVD
Alinity i TSH Assay File
Abbott GmbH
07P481A
In Commercial Distribution

  • 00380740138899 ()
07P481A

  • Laboratory instrument/analyser application software IVD
ARCHITECT i System e-Assay CD-ROM
ABBOTT LABORATORIES
4P55-15
Not in Commercial Distribution

  • 00380740138608 ()
04P5515

  • Laboratory instrument/analyser application software IVD
Alinity i CA 15-3 Controls
Abbott GmbH
08P5110
In Commercial Distribution

  • 00380740135430 ()
08P5110

  • Cancer antigen 15-3 (CA15-3) IVD, control
Alinity i Intact PTH Calibrators
Abbott GmbH
08P3101
Not in Commercial Distribution

  • 00380740131586 ()
08P3101

  • Parathyroid hormone (PTH) IVD, calibrator
Alinity i HAVAb IgM Calibrator
Abbott GmbH
08P2801
In Commercial Distribution

  • 00380740131562 ()
08P2801

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, calibrator
Alinity i CA 15-3 Calibrators
Abbott GmbH
08P5101
In Commercial Distribution

  • 00380740131425 ()
08P5101

  • Cancer antigen 15-3 (CA15-3) IVD, calibrator
Alinity i HAVAb IgG Controls
Abbott GmbH
08P2710
In Commercial Distribution

  • 00380740131364 ()
08P2710

  • Hepatitis B virus core antigen IVD, calibrator
Alinity i Free T3 Calibrators
ABBOTT IRELAND
07P6901
In Commercial Distribution

  • 00380740131081 ()
07P6901

  • Free triiodothyronine (FT3) IVD, calibrator
Alinity i UCH-L1 Assay File
Abbott GmbH
04W191B
In Commercial Distribution

  • 00380740208936 ()
04W191B

  • Laboratory instrument/analyser application software IVD
Alinity i TBI Assay File
Abbott GmbH
04Z231B
In Commercial Distribution

  • 00380740208912 ()
04Z231B

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgNx_C2 Assay File
Abbott GmbH
01R659A
In Commercial Distribution

  • 00380740202910 ()
01R659A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAgNx_ Assay File
Abbott GmbH
01R643A
In Commercial Distribution

  • 00380740202880 ()
01R643A

  • Laboratory instrument/analyser application software IVD
Alinity i Toxo IgM Controls
Abbott GmbH
07P4714
In Commercial Distribution

  • 00380740200633 ()
07P4714

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control
Alinity i Toxo IgM Calibrator
Abbott GmbH
07P4704
In Commercial Distribution

  • 00380740200626 ()
07P4704

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, calibrator
Alinity i Anti-CCP Assay File
Abbott GmbH
09P271B
In Commercial Distribution

  • 00380740200060 ()
09P271B

  • Laboratory instrument/analyser application software IVD
Alinity i UCH-L1 Assay File
Abbott GmbH
04W191A
In Commercial Distribution

  • 00380740198985 ()
04W191A

  • Laboratory instrument/analyser application software IVD
Alinity i TBI Assay File
Abbott GmbH
04Z231A
In Commercial Distribution

  • 00380740198978 ()
04Z231A

  • Laboratory instrument/analyser application software IVD
Alinity i GFAP Assay File
Abbott GmbH
04W171A
In Commercial Distribution

  • 00380740198961 ()
04W171A

  • Laboratory instrument/analyser application software IVD
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