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Manufacturers
Integrated Science Systems Inc
Manufacturer Address
Integrated Science Systems Inc, 1215 George C Wilson Dr Unit A4, Augusta GA 30909-5700
Manufacturer Parent Company (2017)
Integrated Science Systems Inc.
Source
USFDA
1 Event
Recall of Device Recall Sure Vue Color Staph IDSure Vue SELECT Staph IDbiokit Color Staph IDbiokit SELECT Staph ID
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One device in the database
Device Recall Sure Vue Color Staph IDSure Vue SELECT Staph IDbiokit Color Staph IDbiokit SELECT ...
Model / Serial
Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide distribution to CA only.
Product Description
Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T || The product is used as an aid in the identification of Staphylococcus aureus from Culture
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