FDA-Device2020-12-16Class II
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Chromsystems Instruments & Chemicals GmbH
Hazard
XXX
Sold states
Worldwide distribution - US Nationwide distribution in the states of CA and NY; The countries of Australia, Belgium, Brazil, Germany, Finland, France, Greece, Israel, Italy, Canada, Croatia, Kuwait, Austria, Russia, Switzerland, South Africa, Taiwan, Turkey, and United Arab Emirates.
Affected count
342 vials
Manufactured in
Am Haag 12, N/A, Grafelfing, N/A, Germany
Products
MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0539-2021Don't want to check this manually?
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