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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Alinity i Anti-HBs Calibrators (LN 07P8801); Alinity i Anti-HBs Controls (LN 07P8810); Alinity i Anti-HBs Reagent Kit (LN 07P8851, 07P8856); Alinity i Anti-HBs Reagent Kit (LN 07P8852, 07P8857); Alinity i Anti-HBs Specimen Diluent (LN 07P8841); ARCHITECT AUSAB Calibrators (LN 1L82-02, 1L82-03); ARCHITECT AUSAB Controls (LN 1L82-12, 1L82-13); ARCHITECT AUSAB Reagent Kit (LN 1L82-25, 1L82-35, 1L82-26, 1L82-27, 1L82-36, 1L82-37); ARCHITECT AUSAB Reagent Kit (LN 1L82-28, 1L82-38); ARCHITECT AUSAB Specimen Diluent (LN 1L82-40)
Classification Name: TEST, HEPATITIS B (B ANTIGEN, B SURFACE ANTIGEN, BE ANTIGEN)
Product Code: LOM
Device Class: 2
Regulation Number: 866.3172
Medical Specialty: Microbiology
Registered Establishment Name: ABBOTT GmbH
Registered Establishment Number: 3002809144
Premarket Submission Number: P050051
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Foreign Exporter
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