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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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Calibration of Lp(a) assay on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873686
In Commercial Distribution

  • 00630414287430 ()
  • 00630414285009 ()
OQCV07

  • Lipoprotein A IVD, calibrator
No Description
Roche Diagnostics GmbH
5852641160
In Commercial Distribution

  • 04015630933914 ()
5852641160

  • Lipoprotein A IVD, calibrator
No Description
Roche Diagnostics GmbH
05852641190
In Commercial Distribution

  • 04015630930609 ()
05852641190

  • Lipoprotein A IVD, calibrator
Lp(a) Control Set must only be used to verify the performance of the Lp(a) test. Use the Control material like the specimens, according to the indicated analytical procedure.
SENTINEL CH. SPA
1152201
In Commercial Distribution

  • 08058056681744 ()
1152201

  • Lipoprotein A IVD, control
Lp(a) Cal Set should be used as calibration curve for the Lp(a) Ultra test. Use the Calibrator according to the indicated analytical procedure.
SENTINEL CH. SPA
11522D
In Commercial Distribution

  • 08058056680228 ()
11522D

  • Lipoprotein A IVD, calibrator
The Lp(a) Ultra assay is intended for in vitro diagnostic use in the immunoturbidimetric quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma using an automated analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation. For In Vitro Diagnostic use.
SENTINEL CH. SPA
11504D
In Commercial Distribution

  • 08058056680211 ()
11504D

  • Lipoprotein A IVD, reagent
anti-Chromogranin A Rabbit Polyclonal Antibody, Concentrate, 1 mL
SAKURA FINETEK U.S.A., INC.
61-0015
In Commercial Distribution

  • 00615233005199 ()
61-0015

  • Chromogranin A IVD, antibody
anti-Napsin A Rabbit Monoclonal Antibody [EP205], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8331-C010
In Commercial Distribution

  • 00615233001696 ()
8331-C010

  • Napsin A IVD, antibody
anti-Chromogranin A Mouse Monoclonal Antibody [LK2H10], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8286-M250
In Commercial Distribution

  • 00615233001085 ()
8286-M250

  • Chromogranin A IVD, antibody
anti-Chromogranin A Rabbit Polyclonal Antibody, Ready-To-Use, 7 mL
SAKURA FINETEK U.S.A., INC.
60-0015-7
In Commercial Distribution

  • 00615233006745 ()
60-0015-7

  • Chromogranin A IVD, antibody
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