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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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No Description
Fuzhou Maixin Biotech Co., Ltd.
MAB-0704 1.0mL
In Commercial Distribution

  • 06931988303583 ()


  • Napsin A IVD, antibody
No Description
Fuzhou Maixin Biotech Co., Ltd.
MAB-0704 0.2mL
In Commercial Distribution

  • 06931988303576 ()


  • Napsin A IVD, antibody
No Description
Fuzhou Maixin Biotech Co., Ltd.
MAB-0707 90mL
In Commercial Distribution

  • 06931988330855 ()


  • Chromogranin A IVD, antibody
No Description
Fuzhou Maixin Biotech Co., Ltd.
MAB-0891 90mL
In Commercial Distribution

  • 06931988330688 ()


  • Inhibin A IVD, antibody
For the calibration of the K-ASSAY® Lp(a) assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-018C
In Commercial Distribution

  • 00816426020573 ()
KAI-018C

  • Lipoprotein A IVD, calibrator
For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-044
In Commercial Distribution

  • 00816426020245 ()
KAI-044

  • Lipoprotein A IVD, reagent
For the quantitative determination of human lipoprotein(a) [Lp(a)] in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-017
Not in Commercial Distribution

  • 00816426020122 ()
KAI-017

  • Lipoprotein A IVD, reagent
Pointe Lp(a) Reagent packaged for use on the Mindray BA800. 2 x 60ml R1, 2 x 20ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
POINTE SCIENTIFIC, INC.
16-L7597-160
In Commercial Distribution

  • 00811727016225 ()
16-L7597-160

  • Lipoprotein A IVD, reagent
Pointe Lp(a) Reagent packaged for use on the Mindray BS480. 4 x 40ml R1, 4 x 14ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
POINTE SCIENTIFIC, INC.
14-L7597-216
In Commercial Distribution

  • 00811727015921 ()
14-L7597-216

  • Lipoprotein A IVD, reagent
Pointe Lipoprotein (a) Control Set, 1 x 1ml L1, 1 x 1ml L2, For use in monitoring the quality control of results obtained with the Pointe Lipoprotein(a) Assay reagents by turbidimetry. For in vitro diagnostic use.
POINTE SCIENTIFIC, INC.
L7597-CTL
In Commercial Distribution

  • 00811727015594 ()
L7597-CTL

  • Lipoprotein A IVD, control
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