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510(k) Data Aggregation
K Number
DEN180056Device Name
GSP Neonatal Creatine Kinase - MM kit
Manufacturer
PerkinElmer Inc.
Date Cleared
2019-12-12
(427 days)
Product Code
QJE
Regulation Number
862.1506Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GSP Neonatal Creatine Kinase-MM kit, is intended for the quantitative in vitro determination of creatine kinase MM-isoform (CK-MM) concentration in blood specimens dried on filter paper as an aid in screening newborns for Duchenne Muscular Dystrophy (DMD) using the GSP instrument.
Device Description
The GSP Neonatal Creatine Kinase-MM assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique and utilizes standard PerkinElmer DELFIA chemistry with the GSP instrument. The kit contains:
- . The CK-MM Calibrators (containing 0, 30, 120, 500, 2000 and 8000 ng/mL of creatine kinase) consisting of 7 cassettes each containing 1 set of dried blood spots.
- The CK-MM Controls (containing 130, 500 and 2000 ng/mL of creatine kinase) consisting of 5 cassettes each containing 2 set of dried blood spots.
- Anti-CK-MM-Eu Tracer ●
- CK-MM Assay Buffer ●
- Anti-CK-MM Microtitration strips ●
- Extra barcodes for the plates ●
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