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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Test System NameGermaine Laboratories, Inc. AimTab BilirubinTablets  (Urine, qualitative bilirubin)
Document NumberX130001
Parent Document NumberX130001
Analyte NameUrine dipstick or tablet analytes, nonautomated
Analyte SpecialtyUrinalysis
ComplexityWAIVED
Effective Date05/13/2013
Device NameAimTab Bilirubin Tablet
510(K) Exempt NumberX130001
Device Classification NameDiazo Colorimetry, Bilirubin
Product CodeCIG
Regulation Number862.1110
Panel Name Clinical Chemistry
Applicant
GERMAINE LABORATORIES, INC.
11030 wye drive
san antonio,  Tx  78217
Contactnathan o'connor
Date Received01/08/2013
Decision Date 05/13/2013
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