4 results
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20ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
FDA Enforcement
Class II
·Ongoing·Stanbio Laboratory, LP·December 13, 2023
RaPET¿ RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET¿ RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·March 21, 2018
Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·September 5, 2018
Separation Technology Creamatocrit Plus, Catalog Number: 100-146
FDA Enforcement
Class II
·Terminated·Stanbio Laboratory, LP·April 20, 2022