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 s HTLV I/II e-Assay File
Abbott GmbH
06P075A
In Commercial Distribution

  • 00380740162948 ()
06P075A

  • Laboratory instrument/analyser application software IVD
Alinity i DHEA-S Reagent Kit 200 Tests
Abbott GmbH
09P3720
In Commercial Distribution

  • 00380740156336 ()
09P3720

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Alinity i Tacrolimus Reagent Kit 200 Tests
Abbott Ireland Diagnostics
09P4220
In Commercial Distribution

  • 00380740154516 ()
09P4220

  • Tacrolimus therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Alinity i C-Peptide Reagent Kit 200 Tests
Abbott GmbH
09P3620
In Commercial Distribution

  • 00380740154493 ()
09P3620

  • C-peptide IVD, kit, chemiluminescent immunoassay
Alinity i Anti-TPO Reagent Kit 200 Tests
Abbott Ireland Diagnostics
09P3521
In Commercial Distribution

  • 00380740153892 ()
09P3521

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay
Alinity i Homocysteine Reagent Kit 200 Tests
Abbott GmbH
09P2820
In Commercial Distribution

  • 00380740153496 ()
09P2820

  • Homocysteine IVD, kit, chemiluminescent immunoassay
Alinity i Anti-CCP Reagent Kit 200 Tests
Abbott GmbH
09P2720
In Commercial Distribution

  • 00380740151362 ()
09P2720

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBs Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
07P8856
In Commercial Distribution

  • 00380740149611 ()
07P8856

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBs Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P8851
In Commercial Distribution

  • 00380740149604 ()
07P8851

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay
Alinity i Anti-Tg Reagent Kit 200 Tests
Abbott Ireland Diagnostics
09P3420
In Commercial Distribution

  • 00380740149550 ()
09P3420

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Alinity i CA 125 II Assay File
Abbott GmbH
08P491A
In Commercial Distribution

  • 00380740146603 ()
08P491A

  • Laboratory instrument/analyser application software IVD
Alinity i HIV Ag/Ab Combo Calibrator
Abbott GmbH
08P0702
In Commercial Distribution

  • 00380740146252 ()
08P0702

  • HIV1/HIV2 antigen/antibody IVD, calibrator
Alinity i HE4 Reagent Kit 200 Tests
Abbott GmbH
08P5021
In Commercial Distribution

  • 00380740138349 ()
08P5021

  • Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBc Reagent Kit 200 Tests
Abbott GmbH
07P8421
In Commercial Distribution

  • 00380740136659 ()
07P8421

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Alinity i FSH Reagent Kit 1200 Tests
ABBOTT IRELAND
07P4930
In Commercial Distribution

  • 00380740131647 ()
07P4930

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Alinity i T-Uptake Reagent Kit 200 Tests
Abbott Ireland Diagnostics
08P1220
In Commercial Distribution

  • 00380740131548 ()
08P1220

  • Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay
Alinity i TSH Reagent Kit 1200 Tests
ABBOTT IRELAND
07P4830
In Commercial Distribution

  • 00380740131159 ()
07P4830

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Alinity i TSH Reagent Kit 200 Tests
ABBOTT IRELAND
07P4820
In Commercial Distribution

  • 00380740131142 ()
07P4820

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Alinity i CEA Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
07P6230
In Commercial Distribution

  • 00380740130862 ()
07P6230

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Alinity i AFP Reagent Kit 1200 Tests
Abbott Ireland Diagnostics
07P9030
In Commercial Distribution

  • 00380740130824 ()
07P9030

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Alinity i AFP Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P9020
In Commercial Distribution

  • 00380740130817 ()
07P9020

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Alinity i Sirolimus Reagent Kit 200 Tests
Abbott Ireland Diagnostics
09P4120
In Commercial Distribution

  • 00380740150990 ()
09P4120

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Alinity i Insulin Reagent Kit 200 Tests
Abbott GmbH
04T7520
In Commercial Distribution

  • 00380740150815 ()
04T7520

  • Insulin IVD, kit, chemiluminescent immunoassay
Alinity i B12 Reagent Kit 1200 Tests
ABBOTT IRELAND
07P6731
In Commercial Distribution

  • 00380740136703 ()
07P6731

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Alinity i B12 Reagent Kit 200 Tests
ABBOTT IRELAND
07P6721
In Commercial Distribution

  • 00380740136697 ()
07P6721

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Alinity i Anti-HBc Reagent Kit 1200 Tests
Abbott GmbH
07P8431
In Commercial Distribution

  • 00380740136666 ()
07P8431

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay
Alinity i HIV Ag/Ab Combo Controls
Abbott GmbH
08P0712
In Commercial Distribution

  • 00380740136574 ()
08P0712

  • HIV1/HIV2 antigen/antibody IVD, control
Alinity i Folate Reagent Kit 1200 Tests
ABBOTT IRELAND
08P1431
In Commercial Distribution

  • 00380740136567 ()
08P1431

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Alinity i Folate Reagent Kit 200 Tests
ABBOTT IRELAND
08P1421
In Commercial Distribution

  • 00380740136550 ()
08P1421

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Alinity i FSH Reagent Kit 200 Tests
ABBOTT IRELAND
07P4920
In Commercial Distribution

  • 00380740131630 ()
07P4920

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Alinity i Ferritin Reagent Kit 1200 Tests
ABBOTT IRELAND
07P6530
In Commercial Distribution

  • 00380740131487 ()
07P6530

  • Ferritin IVD, kit, chemiluminescent immunoassay
Alinity i Ferritin Reagent Kit 200 Tests
ABBOTT IRELAND
07P6520
In Commercial Distribution

  • 00380740131470 ()
07P6520

  • Ferritin IVD, kit, chemiluminescent immunoassay
Alinity i Folate Manual Diluent 1 Tests
ABBOTT IRELAND
08P1460
In Commercial Distribution

  • 00380740130923 ()
08P1460

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Alinity i CEA Reagent Kit 200 Tests
Abbott Ireland Diagnostics
07P6220
In Commercial Distribution

  • 00380740130855 ()
07P6220

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Alere NT-proBNP for Alinity I Assay File
Abbott GmbH
04S793A
In Commercial Distribution

  • 00380740216085 ()
04S793A

  • Laboratory instrument/analyser application software IVD
Alinity i HBsAg Next Confirmatory Manual Diluent
Abbott Ireland Diagnostics
01R6542
In Commercial Distribution

  • 00380740214289 ()
01R6542

  • Buffered sample diluent IVD
20° Posterior shade I, mould 34M, L
The Myerson Company Limited
T540IL034M
In Commercial Distribution

  • 00842326168442 ()


  • Resin artificial teeth
20° Posterior shade I, mould 32L, L
The Myerson Company Limited
T540IL032L
In Commercial Distribution

  • 00842326168435 ()


  • Resin artificial teeth
20° Posterior shade I, mould 32M, L
The Myerson Company Limited
T540IL032M
In Commercial Distribution

  • 00842326168428 ()


  • Resin artificial teeth
20° Posterior shade I, mould 30LS, L
The Myerson Company Limited
T540IL30LS
In Commercial Distribution

  • 00842326168411 ()


  • Resin artificial teeth
20° Posterior shade I, mould 30L, L
The Myerson Company Limited
T540IL030L
In Commercial Distribution

  • 00842326168404 ()


  • Resin artificial teeth
20° Posterior shade I, mould 30M, L
The Myerson Company Limited
T540IL030M
In Commercial Distribution

  • 00842326168398 ()


  • Resin artificial teeth
20° Posterior shade I, mould 28L, L
The Myerson Company Limited
T540IL028L
In Commercial Distribution

  • 00842326168381 ()


  • Resin artificial teeth
20° Posterior shade I, mould 28M, L
The Myerson Company Limited
T540IL028M
In Commercial Distribution

  • 00842326168374 ()


  • Resin artificial teeth
20° Posterior shade I, mould 34M, U
The Myerson Company Limited
T540IU034M
In Commercial Distribution

  • 00842326168367 ()


  • Resin artificial teeth
20° Posterior shade I, mould 32L, U
The Myerson Company Limited
T540IU032L
In Commercial Distribution

  • 00842326168350 ()


  • Resin artificial teeth
20° Posterior shade I, mould 32M, U
The Myerson Company Limited
T540IU032M
In Commercial Distribution

  • 00842326168343 ()


  • Resin artificial teeth
20° Posterior shade I, mould 30LS, U
The Myerson Company Limited
T540IU30LS
In Commercial Distribution

  • 00842326168336 ()


  • Resin artificial teeth
20° Posterior shade I, mould 30L, U
The Myerson Company Limited
T540IU030L
In Commercial Distribution

  • 00842326168329 ()


  • Resin artificial teeth
20° Posterior shade I, mould 30M, U
The Myerson Company Limited
T540IU030M
In Commercial Distribution

  • 00842326168312 ()


  • Resin artificial teeth
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