FDA-Device2020-12-16Class II
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - 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
Products do not meet stability criteria and may impact results.
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
200 packaging units
Manufactured in
Am Haag 12, N/A, Grafelfing, N/A, Germany
Products
3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - 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-0536-2021Don't want to check this manually?
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