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International Document Library

Click on the document links below for the appropriate documentation for that product.
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* D of C is the European Declaration of Conformity

General Documents
Rapid Diagnostics (San Diego, CA)
EN ISO 13485 Certificate  
TUV EC Certificate for Chlamydia  
ISO 13485 with CMDCAS Certificate  
Molecular Diagnostics, Cell Culture & Fluorescent Antibody Kits, Bone Health and Autoimmune & Complement (Athens, OH)
EN ISO 13485 Certificate  
EC Certificate (TUV) for Chlamydia, CMV, and associated products  
ISO 13485 with CMDCAS Certificate  
 
Rapid Immunofluorescent Diagnostics
Sofia®
Name Cat No D of C* CLIA Letter
Sofia Analyzer 20221    
Sofia hCG 20229/20266    
Sofia Influenza A+B 20218/20254    
Sofia Legionella 20244    
Sofia RSV 20242/20260    
Sofia Strep A 20231/20253    
Sofia S. pneumoniae 20293    
 
Virena®
Name Cat No D of C* CLIA Letter
Virena Surveillance System      
 
Rapid Diagnostics
Chlamydia
Name Cat No D of C* CLIA Letter
QuickVue Chlamydia 0B006    
QuickVue Chlamydia Sampler 0B008    
 
Strep A
Name Cat No D of C* CLIA Letter
QuickVue In-Line Strep A 00343/00343IN    
QuickVue+ Strep A 20122/20122IN    
QuickVue Dipstick Strep A 20108/20108IN    
QuickVue Dipstick Strep A 20125    
QuickVue Dipstick Strep A Sampler 20163    
 
Pregnancy
Name Cat No D of C* CLIA Letter
QuickVue+ hCG Combo (W) 00178    
QuickVue+ hCG Combo (MC) 00178    
QuickVue+ hCG Combo (W) 00179    
QuickVue+ hCG Combo (MC) 00179    
QuickVue hCG Urine 20109/20109IN    
QuickVue hCG Combo (W) 20110/20110IN    
QuickVue hCG Combo (MC) 20110    
 
H. pylori
Name Cat No D of C* CLIA Letter
QuickVue H. pylori gII (W) 0W009    
QuickVue H. pylori gII (MC) 0W009    
QuickVue H. pylori gII (W) 0W010    
QuickVue H. pylori gII (MC) 0W010    
 
Influenza
Name Cat No D of C* CLIA Letter
QuickVue Influenza 00317/00317IN    
QuickVue Influenza A+B 20183/20183IN    
QuickVue Influenza A+B Sampler 20185    
 
RSV
Name Cat No D of C* CLIA Letter
QuickVue RSV 20193    
QuickVue RSV Sampler 20199    
 
Bone Markers
Name Cat No D of C* CLIA Letter
MicroVue Osteocalcin 8002    
MicroVue CICP 8003    
MicroVue DPD 8007    
MicroVue PYD 8010    
MicroVue BAP 8012    
MicroVue TRAP5b EIA Kit 8036    
MicroVue 25-OH Vitamin D 8046    
Autoimmune & Complement
Name Cat No D of C* CLIA Letter
MicroVue CIC-C1q EIA A001    
MicroVue CIC-C1q Controls A013    
MicroVue CIC-Raji Cell Replacement EIA (CIC-C3d EIA) A002    
MicroVue C1 Inhibitor EIA A003    
MicroVue C4d EIA Kit A008    
MicroVue C3a Plus EIA Kit A032    
MicroVue C5a EIA Kit A025    
MicroVue Bb Plus EIA Kit A027    
MicroVue CH50 Eq EIA Kit A018    
MicroVue SC5b-9 Plus EIA Kit A029    
MicroVue Ba EIA Kit A034    
MicroVue C4a EIA Kit A036    
MicroVue C1 Inhibitor Plus EIA Kit A037