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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 112-4793355-4/1/1

Manufacturer FEI3007329294
Manufacturer NameHangzhou Ausia Biological Techni  
Manufacturer Address line 11# No 1 Street Hanzhou Ecomic An  
Manufacturer Address line 2  
Manufacturer's CityHangzhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code82MZF  
FDA Product DescriptionTEST, HIV DETECTION  
Refusal Date17-Nov-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-4793355-4/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO PMA   501(f)(1)(B), 801(a)(3); ADULTERATION   The article appears to be a class III device without an approved application for premarket approval pursuant to section 515(a).  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).