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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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CARDINAL HEALTH - 20885380096737

CRYPTO GIARDIA KIT
Cardinal Health 200, LLC
CH6830
In Commercial Distribution

  • 50885380096738 ()
  • 20885380096737 ()
  • 10885380096730 ()
CH6830

  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical

NA - 00848838026874

Xpect Giardia/Crypto KT/20TST
REMEL, INC.
R2450520
In Commercial Distribution

  • 00848838026874 ()
  • 00848838099779 ()


  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical

Tissue-Tek VIP® 6 - 04946433600539

AI
SAKURA FINETEK U.S.A., INC.
6040
In Commercial Distribution

  • 04946433600539 ()
6040

  • Tissue processor IVD, automated/semi-automated

TRITON - 00859506006173

TRITON AI
STRYKER CORPORATION
GAUS-6
In Commercial Distribution

  • 00859506006173 ()
GAUS-6

  • Blood loss estimation application software

Triton - 07613327622768

AI Software
STRYKER CORPORATION
0894000001
In Commercial Distribution

  • 07613327622768 ()
0894-000-001

  • Blood loss estimation application software

Beltone - 05708296136346

AI SHOE 75
Gn Hearing A/S
15682000
In Commercial Distribution

  • 05708296136346 ()


  • Hearing aid/implant system functionality-enhancing device

N/A - 07613327622782

SC+ AI Software
STRYKER CORPORATION
0894000004
In Commercial Distribution

  • 07613327622782 ()
0894-000-004

  • Blood loss estimation application software

N/A - 00810047420804

Crypto Kinyoun Decolorizer [250ml x 6 bottles/pkg]
Scientific Device Laboratory, Inc.
379-B
In Commercial Distribution

  • 00810047420804 ()


  • Biological stain IVD

VITROS - 10758750001385

VITROS Chemistry Products ApoB Performance Verifier I
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801770
In Commercial Distribution

  • 10758750001385 ()
6801770

  • Apolipoprotein A-I (Apo A1) IVD, control

VITROS - 10758750001378

VITROS Chemistry Products ApoA1 Performance Verifier I
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801769
In Commercial Distribution

  • 10758750001378 ()
6801769

  • Apolipoprotein A-I (Apo A1) IVD, control

Atellica CH APO A1 - 00630414596242

Apolipoprotein A-1 (APO A1) Atellica CH - RGT 300T
Siemens Healthcare Diagnostics Inc.
11097625
In Commercial Distribution

  • 00630414596242 ()
11097625

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

ADVIA® Chemistry APO A1 Reagents - 00630414517636

Apolipoprotein A1 - ADVIA Chem. - RGT - 2x75 tests
Siemens Healthcare Diagnostics Inc.
10318196
In Commercial Distribution

  • 00630414517636 ()
3050910

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Human Apolipoprotein A-1 (Apo A-1) kit for use on SPAPLUS - 05051700016872

No Description
THE BINDING SITE GROUP LIMITED
NK085.S
In Commercial Distribution

  • 05051700016872 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

APOLIPOPROTEIN A-I (APO A-I) - 05055273209211

No Description
RANDOX LABORATORIES LIMITED
LP8007
In Commercial Distribution

  • 05055273209211 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

APO A-I - 05055273204452

Intended for the quantitative in vitro determination of Apolipoprotein A-I (APO A-I) in serum and plasma
RANDOX LABORATORIES LIMITED
LP3838
In Commercial Distribution

  • 05055273204452 ()
LP3838

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

APO A-I - 05055273204360

Intended for the quantitative in vitro determination of Apolipoprotein A-I (APO A-I) in serum and plasma
RANDOX LABORATORIES LIMITED
LP2866
Not in Commercial Distribution

  • 05055273204360 ()
LP2866

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

APO A-I - 05055273204339

Intended for the quantitative in vitro determination of Apolipoprotein A-I (APO A-I) in serum and plasma
RANDOX LABORATORIES LIMITED
LP2116
In Commercial Distribution

  • 05055273204339 ()
LP2116

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

APO A-I - 05055273204391

Intended for the quantitative in vitro determination of Apolipoprotein A-I (APO A-I) in serum and plasma
RANDOX LABORATORIES LIMITED
LP2989
In Commercial Distribution

  • 05055273204391 ()
LP2989

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Tina-quant Apolipoprotein A-1 ver.2 - 07613336133521

No Description
Roche Diagnostics GmbH
08105448190
In Commercial Distribution

  • 07613336133521 ()
08105448190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Diazyme - 00817089020016

No Description
DIAZYME LABORATORIES, INC.
DZ141A-K
In Commercial Distribution

  • 00817089020016 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632 - 00817302020885

APO A1 (Apolipoprotein A1) 3 x 200 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
AU-632
Not in Commercial Distribution

  • 00817302020885 ()

  • Kit contains 3 R1 and 3 R2 bottles and 1 package insert
  • Total Volume: 46 Milliliter
  • Total Volume: 16 Milliliter
AU-632

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT BL-632 - 00817302020878

APO A1 (Apolipoprotein A1) 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL632
Not in Commercial Distribution

  • 00817302020878 ()

  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 8 Milliliter
  • Total Volume: 23 Milliliter
BL632

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

VITROS - 10758750006861

VITROS Chemistry Products ApoA1 Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801737
In Commercial Distribution

  • 10758750006861 ()
  • 20758750006868 ()
6801737

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Alinity - 00380740153908

Alinity c Apolipoprotein A1 Reagent Kit 190 Tests
Abbott GmbH
09P4620
In Commercial Distribution

  • 00380740153908 ()
09P4620

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

ARCHITECT - 00380740175139

Apolipoprotein A1
Abbott GmbH
9D92-22
In Commercial Distribution

  • 00380740175139 ()
09D9222

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Apolipoprotein A-I - 00842768011269

Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446438
In Commercial Distribution

  • 00842768011269 ()
OUED15

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

N Antiserum to Human Apolipoprotein A-I - 00842768011252

Quantitative determination of apolipoprotein A-I in human serum and plasma on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446437
In Commercial Distribution

  • 00842768011252 ()
OUED09

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Dimension Vista® Apolipoprotein AI Flex® reagent cartridge - 00842768006012

For the quantitative measurement of apolipoprotein A-I in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445886
In Commercial Distribution

  • 00842768006012 ()
  • 00842768019890 ()
K7018

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

AI ver2 Tinaquant Apolipoprotein AI ver2 - 04015630917747

No Description
Roche Diagnostics GmbH
3032612122
In Commercial Distribution

  • 04015630917747 ()
3032612122

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Tinaquant Apolipoprotein A1 ver2 - 04015630917723

No Description
Roche Diagnostics GmbH
3032566122
In Commercial Distribution

  • 04015630917723 ()
3032566122

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Tinaquant Apolipoprotein AI ver2 - 04015630930227

No Description
Roche Diagnostics GmbH
6301703190
In Commercial Distribution

  • 04015630930227 ()
6301703190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Tinaquant Apolipoprotein A1 ver2 - 04015630928651

No Description
Roche Diagnostics GmbH
5950686190
In Commercial Distribution

  • 04015630928651 ()
5950686190

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

Synchron - 15099590229931

Apolipoprotein A Reagent (ApoA 2 x 100)
Beckman Coulter, Inc.
467900
In Commercial Distribution

  • 15099590229931 ()
467900

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

IMMAGE - 15099590223878

IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent
Beckman Coulter, Inc.
446410
In Commercial Distribution

  • 15099590223878 ()
446410

  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

AU - 15099590010393

APO A1
Beckman Coulter, Inc.
OSR6142
In Commercial Distribution

  • 15099590010393 ()


  • Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

VITROS - 10758750006700

VITROS Chemistry Products Calibrator Kit 22
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801706
In Commercial Distribution

  • 10758750006700 ()
6801706

  • Apolipoprotein A-I (Apo A1) IVD, calibrator

Medline Industries, Inc. - 10193489947168

HEART AI VASCULAR TRAY
MEDLINE INDUSTRIES, INC.
DYNJ69470
In Commercial Distribution

  • 10193489947168 ()
  • 40193489947169 ()
DYNJ69470

  • General surgical procedure kit, non-medicated, single-use

TRITON - 00859506006081

Triton AI Calibration Placard
STRYKER CORPORATION
FG-12008
In Commercial Distribution

  • 00859506006081 ()
  • 10859506006088 ()
FG-12008

  • Blood loss estimation canister insert/label

Caption - 00198953030233

Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution

  • 00198953030233 ()


  • Ultrasound imaging system application software

K-ASSAY® Apo AI Reagent - 00816426020016

For the quantitative determination of human apolipoprotein AI (Apo AI) in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-002
In Commercial Distribution

  • 00816426020016 ()
KAI-002

  • Apolipoprotein A-I (Apo A1) IVD, reagent
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