• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
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 NameHYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST
Classification Namekit, dna detection, human papillomavirus
Generic Namehuman papillomavirus dna detection kit
ApplicantDIGENE CORP.
PMA NumberP890064
Supplement NumberS013
Date Received10/02/2003
Decision Date11/07/2003
Product Code
MAQ[ Registered Establishments with MAQ ]
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) modification of hybridization procedural steps and sequence; this modification entails reversing the addition order of the hpv rna probes and denatured specimen with no change in probe or specimen volume. An additional 10 minute incubation period at room temperature (15 degrees c to 30 degrees c) was added after removal of the specimen from the 65 += 2 degrees c, 60 minutes hybridization incubation step. 2) addition of an equivocal result zone, which requires repeating specimens that have results within this result zone, for specimens collected in preservcyt transport medium. This equivocal result zone has been established to be >=1. 0 and <+ 2. 5 rlu/co. 3)_ removal of the equivocal result zone from specimens collected in the digene specimen transport medium.
-
-