Quality Control Kits For Bloodborne Pathogen Testing Of Donors

Kit, Test (donors), For Bloodborne Pathogen

BBI Diagnostics, A SeraCare Company

The following data is part of a premarket notification filed by Bbi Diagnostics, A Seracare Company with the FDA for Quality Control Kits For Bloodborne Pathogen Testing Of Donors.

Pre-market Notification Details

Device IDBK060022
510k NumberBK060022
Device Name:Quality Control Kits For Bloodborne Pathogen Testing Of Donors
ClassificationKit, Test (donors), For Bloodborne Pathogen
Applicant BBI Diagnostics, A SeraCare Company 375 West Street West Bridgewater,  MA  02379
Product CodeMYZ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-25
Decision Date2006-06-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816784020901 BK060022 0

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