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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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Actalyke XL, Dual Detection, (Display #2) "CE" (110V/220V) - M52557700020

No Description
HELENA LABORATORIES CORPORATION
5770002
In Commercial Distribution

  • M52557700020 ()


  • Coagulation analyser IVD, laboratory

Actalyke Thermometer - M52557570000

No Description
HELENA LABORATORIES CORPORATION
5757000
In Commercial Distribution

  • M52557570000 ()


  • Coagulation analyser IVD, laboratory

Actalyke Mini II, w/o Printer & Battery., "CE" (110V/220V) - M52557550000

No Description
HELENA LABORATORIES CORPORATION
5755000
In Commercial Distribution

  • M52557550000 ()


  • Coagulation analyser IVD, laboratory

Cuvettes (2400 cuvettes) - 08426950075899

Cuvettes (2400 cuvettes)
INSTRUMENTATION LABORATORY COMPANY
00029400100
In Commercial Distribution

  • 08426950075899 ()
  • 18426950075896 ()
00029400100

  • Coagulation analyser IVD, laboratory

Rotors 100 pcs 2000 wells - 08426950003151

Rotors 100 pcs 2000 wells
INSTRUMENTATION LABORATORY COMPANY
00006800000
In Commercial Distribution

  • 08426950003151 ()
  • 18426950003158 ()
00006800000

  • Coagulation analyser IVD, laboratory

ACL ELITE - 08426950965572

ACL ELITE (Refurbished)
INSTRUMENTATION LABORATORY COMPANY
00000880311R
In Commercial Distribution

  • 08426950965572 ()
00000880311R

  • Coagulation analyser IVD, laboratory

ACL TOP 300 CTS - 08426950928027

ACL TOP 300 CTS (Refurbished)
INSTRUMENTATION LABORATORY COMPANY
00000280060R
In Commercial Distribution

  • 08426950928027 ()
00000280060R

  • Coagulation analyser IVD, laboratory

ACL TOP 700 CTS - 08426950928010

ACL TOP 700 CTS (Refurbished)
INSTRUMENTATION LABORATORY COMPANY
00000280050R
In Commercial Distribution

  • 08426950928010 ()
00000280050R

  • Coagulation analyser IVD, laboratory

ACL TOP 500 CTS - 08426950928003

ACL TOP 500 CTS (Refurbished)
INSTRUMENTATION LABORATORY COMPANY
00000280040R
In Commercial Distribution

  • 08426950928003 ()
00000280040R

  • Coagulation analyser IVD, laboratory

ACL TOP 700 - 08426950927990

ACL TOP 700 (Refurbished)
INSTRUMENTATION LABORATORY COMPANY
00000280010R
In Commercial Distribution

  • 08426950927990 ()
00000280010R

  • Coagulation analyser IVD, laboratory

ACL TOP 550 CTS - 08426950729242

ACL TOP 550 CTS
INSTRUMENTATION LABORATORY COMPANY
00000280045
In Commercial Distribution

  • 08426950729242 ()
00000280045

  • Coagulation analyser IVD, laboratory

HemosIL AcuStar - 08426950498001

ACL AcuStar
INSTRUMENTATION LABORATORY COMPANY
0009801000
In Commercial Distribution

  • 08426950498001 ()
0009801000

  • Coagulation analyser IVD, laboratory

ACL TOP 700 LAS - 08426950497998

ACL TOP 700 SYSTEM, LAS
INSTRUMENTATION LABORATORY COMPANY
00000280030
In Commercial Distribution

  • 08426950497998 ()
00000280030

  • Coagulation analyser IVD, laboratory

ACL TOP 700 CTS - 08426950497981

ACL TOP 700 CTS
INSTRUMENTATION LABORATORY COMPANY
00000280050
In Commercial Distribution

  • 08426950497981 ()
00000280050

  • Coagulation analyser IVD, laboratory

ACL TOP 700 - 08426950497974

ACL TOP 700
INSTRUMENTATION LABORATORY COMPANY
00000280010
In Commercial Distribution

  • 08426950497974 ()
00000280010

  • Coagulation analyser IVD, laboratory

ACL AcuStar cuvettes (1400 pcs) - 08426950497059

ACL AcuStar cuvettes (1400 pcs)
INSTRUMENTATION LABORATORY COMPANY
0009801100
In Commercial Distribution

  • 08426950497059 ()
  • 18426950497056 ()
0009801100

  • Coagulation analyser IVD, laboratory

ACL ELITE PRO - 08426950453482

ACL ELITE PRO (Refurbished)
INSTRUMENTATION LABORATORY COMPANY
00001000311R
In Commercial Distribution

  • 08426950453482 ()
00001000311R

  • Coagulation analyser IVD, laboratory

ACL ELITE - 08426950453017

ACL ELITE
INSTRUMENTATION LABORATORY COMPANY
00000880311
In Commercial Distribution

  • 08426950453017 ()
00000880311

  • Coagulation analyser IVD, laboratory

ACL TOP CTS - 08426950451600

ACL TOP CTS (Refurbished)
INSTRUMENTATION LABORATORY COMPANY
00000280020R
In Commercial Distribution

  • 08426950451600 ()
00000280020R

  • Coagulation analyser IVD, laboratory

Electronic Verification Cartridge Kit - 08426950088523

Electronic Verification Cartridge Kit
INSTRUMENTATION LABORATORY COMPANY
06260020000
Not in Commercial Distribution

  • 08426950088523 ()
06260020000

  • Coagulation analyser IVD, laboratory

Temperature Verification Cartridges - 08426950088516

Temperature Verification Cartridges
INSTRUMENTATION LABORATORY COMPANY
06260019000
Not in Commercial Distribution

  • 08426950088516 ()
06260019000

  • Coagulation analyser IVD, laboratory

ACL TOP 350 CTS - 08426950784081

ACL TOP 350 CTS
INSTRUMENTATION LABORATORY COMPANY
00000280065
In Commercial Distribution

  • 08426950784081 ()
00000280065

  • Coagulation analyser IVD, laboratory

ACL TOP 750 - 08426950784074

ACL TOP 750
INSTRUMENTATION LABORATORY COMPANY
00000280015
In Commercial Distribution

  • 08426950784074 ()
00000280015

  • Coagulation analyser IVD, laboratory

ACL TOP 750 CTS - 08426950784067

ACL TOP 750 CTS
INSTRUMENTATION LABORATORY COMPANY
00000280055
In Commercial Distribution

  • 08426950784067 ()
00000280055

  • Coagulation analyser IVD, laboratory

ACL TOP 750 LAS - 08426950784050

ACL TOP 750 LAS
INSTRUMENTATION LABORATORY COMPANY
00000280035
In Commercial Distribution

  • 08426950784050 ()
00000280035

  • Coagulation analyser IVD, laboratory

ACL TOP 300 CTS - 08426950556916

ACL TOP 300 CTS
INSTRUMENTATION LABORATORY COMPANY
00000280060
In Commercial Distribution

  • 08426950556916 ()
00000280060

  • Coagulation analyser IVD, laboratory

ACL TOP 500 CTS - 08426950453499

ACL TOP 500 CTS
INSTRUMENTATION LABORATORY COMPANY
00000280040
In Commercial Distribution

  • 08426950453499 ()
00000280040

  • Coagulation analyser IVD, laboratory

ACL ELITE PRO - 08426950451570

ACL ELITE PRO
INSTRUMENTATION LABORATORY COMPANY
00001000311
In Commercial Distribution

  • 08426950451570 ()
00001000311

  • Coagulation analyser IVD, laboratory

QStat Cartridge - 10850003761180

For Use with the QUANTRA® Hemostasis Analyzer
HEMOSONICS, LLC
QStat Cartridge KIT (Box of 10)
In Commercial Distribution

  • 00850003761183 ()
  • 10850003761180 ()


  • Coagulation analyser IVD, laboratory

ACL TOP 370 - 00195226000566

ACL TOP 370
INSTRUMENTATION LABORATORY COMPANY
00000280067
In Commercial Distribution

  • 00195226000566 ()
00000280067

  • Coagulation analyser IVD, laboratory

ACL TOP 570 - 00195226000559

ACL TOP 570
INSTRUMENTATION LABORATORY COMPANY
00000280047
In Commercial Distribution

  • 00195226000559 ()
00000280047

  • Coagulation analyser IVD, laboratory

ACL TOP 770s - 00195226000542

ACL TOP 770s
INSTRUMENTATION LABORATORY COMPANY
00000280017
In Commercial Distribution

  • 00195226000542 ()
00000280017

  • Coagulation analyser IVD, laboratory

ACL TOP 770 LAS - 00195226000535

ACL TOP 770 LAS
INSTRUMENTATION LABORATORY COMPANY
00000280037
In Commercial Distribution

  • 00195226000535 ()
00000280037

  • Coagulation analyser IVD, laboratory

ACL TOP 770 - 00195226000528

ACL TOP 770
INSTRUMENTATION LABORATORY COMPANY
00000280057
In Commercial Distribution

  • 00195226000528 ()
00000280057

  • Coagulation analyser IVD, laboratory

BCS® XP System - 00630414945514

The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma
Siemens Healthcare Diagnostics Products GmbH
10459330
In Commercial Distribution

  • 00630414945514 ()
OVOB03

  • Coagulation analyser IVD, laboratory

Automated Blood Coagulation Analyzer CA-600 series CA-660 - 04987562518685

a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use.
SYSMEX CORPORATION
CK978289
In Commercial Distribution

  • 04987562518685 ()


  • Coagulation analyser IVD, laboratory

Automated Blood Coagulation Analyzer CA-600 series CA-620 - 04987562518678

A fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use
SYSMEX CORPORATION
BR142626
In Commercial Distribution

  • 04987562518678 ()


  • Coagulation analyser IVD, laboratory

Automated Blood Coagulation Analyzer CS-2500 - 04987562518661

A fully automated blood coagulation analyzer intended for in vitro diagnostic use.
SYSMEX CORPORATION
BV981798
In Commercial Distribution

  • 04987562518661 ()


  • Coagulation analyser IVD, laboratory

Automated Blood Coagulation Analyzer CS-5100 - 04987562518654

A fully automated blood coagulation analyzer intended for in vitro diagnostic use.
SYSMEX CORPORATION
BY990757
In Commercial Distribution

  • 04987562518654 ()


  • Coagulation analyser IVD, laboratory

Automated Blood Coagulation Analyzer CS-2500 - 04987562433735

CS-2500 COMPLETE
SYSMEX CORPORATION
BV981798
In Commercial Distribution

  • 04987562433735 ()


  • Coagulation analyser IVD, laboratory
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