中文名稱：類風濕因子質控品
英文名稱：Rheumatoid Factor Positive Control (35-RC25)
產品貨號：35-RC25
品牌：Fitzgerald
Certificate of Analysis
Calibrator & Controls Data Sheet
Product：Rheumatoid Factor +ve control
Catalog #：35-RC25
Lot #：
Source：Human plasma.
Concentration：≥1900 IU/ml by Beckman Array Nephelometer.
Contaminants：N/A
Form：Defibrinated / delipidated Plasma with no preservatives added.
Biohazard：This product is manufactured from plasma/serum units collected from U.S. FDA licensed collection centers. All raw material tested non-reactive for Syphilis(STS). Individual units tested negative/non-reactive for HBsAg, HIV-1 Ag (HIV-PCR/HIV genomic test), anti-HIV 1/2 and anti-HCV by FDA approved assays.
Storage：4°C shipping only. Upon receipt store at -20°C.
Additional Remarks：This product has been collected only from U.S. FDA licensed plasma/serum collection centers.All blood used in this lot was purchased through United States Blood Banks and complies with FDAregulations. According to the FDA, in general, respiratory viruses are not known to be transmitted byblood transfusion, and there have been no reported cases of transfusion-transmitted coronavirus.
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