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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
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