FDA-Device2024-08-21Class III
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
DRG International, Inc.
Hazard
Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
Sold states
US Nationwide distribution in the states of CA, IL, MN, PA, UT, VA.
Affected count
257 units
Manufactured in
841 Mountain Ave, Springfield, NJ, United States
Products
Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2622-2024Don't want to check this manually?
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