Device Dossier
Procleix Parvo HAV - Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Device Dossier for Procleix Parvo HAV - Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT) (Hepatitis A/Parvovirus B19…
- GMDN category: Hepatitis A/Parvovirus B19 virus nucleic acid IVD, kit, nucleic acid technique (NAT)
- Sponsor: Grifols
Intended purpose
The Procleix Parvo/HAV Assay for use on the Procleix Panther System is an in vitro nucleic acid amplification test for the quantitative detection of parvovirus B 19 genotypes 1-3 DNA and the qualitative detection of hepatitis A virus (HAV) genotypes I-III in plasma and serum specimens from human donors. Plasma may be tested as individual specimens or pools comprised of aliquots of individual specimens. This assay is not intended for use as an aid in diagnosis.
Functional description
The Procleix Parvo/HAV Assay for use on the Procleix Panther System is an in vitro nucleic acid amplification test for the quantitative detection of parvovirus B 19 genotypes 1-3 DNA and the qualitative detection of hepatitis A virus (HAV) genotypes I-III in plasma and serum specimens from human donors. Plasma may be tested as individual specimens or pools comprised of aliquots of individual specimens. This assay is not intended for use as an aid in diagnosis.