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PSA Ag material number and pack size:
Material Number Pack Size
07190956001 custom fill
Will be supplied as "PSA Ag". Unit of measure is "mg".
Antigen derived from human seminal plasma
For development and manufacturing of target-specific assay reagents.
Highly purified native prostate specific (PSA) antigen derived from human seminal plasma.
Identification (ECLIA): Positive
PSA activity (ECLIA, Roche Elecsys®): >0.5 mg/mL
Purity (SDS PAGE): >96%, cluster of bands at 29 kD
Bioburden: <10 CFU/mL
Viral Marker Test (ELISA) for HBsAg, Anti-HCV and Anti-HIV I + II (US-FDA approved BioRad & Ortho Clinical Diagnostics): Negative
Absence of viral DNA/RNA for (HBV, HIV I and HCV; PCR): Negative
Stability: At +2 to +8°C within specification range for 10 months.