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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device Cambridge Biotech HIV-1 Urine Western Blot
Classification Nametest, hiv detection
Generic Namehiv detection test
Regulation Number866.3956
Applicant
Maxim Biomedical Inc
1265 harbor bay parkway
Alameda , CA 94502 
  
PMA NumberBP010009
Date Received03/12/2001
Decision Date06/21/2001
Decision Approved
Product Code
MZF[ Registered Establishments with MZF ]
Advisory Committee Microbiology
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S001 S002 S003 S004 S005 S006 S008 S017 S024 
S028 S031 S032 
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