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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDIGENE HYBRID CAPTURE 2 HPV DNA TEST
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna detection kit
ApplicantDIGENE CORP.
PMA NumberP890064
Supplement NumberS012
Date Received05/20/2003
Decision Date06/20/2003
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of lot release testing for detection reagent 1 (dr1) component.
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