International

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)
TUV Certificate - 13485 520KB
TUV EC Certificate for Chlamydia 410KB
CMDCAS Certificate 671KB
Autoimmune & Complement (Santa Clara, Ca)
TUV Certificate - 13485 307KB
Rapid Immunofluorescent Diagnostics
Sofia®
Name Cat No D of C* CLIA Letter
Sofia Analyzer 20221 388KB 63KB
Sofia Influenza A+B 20218 388KB 63KB
Sofia Strep A 20231 556KB  
Rapid Diagnostics
Chlamydia
Name Cat No D of C* CLIA Letter
QuickVue Chlamydia 0B006 20KB 22KB
QuickVue Chlamydia Sampler 0B008    

Strep A
Name Cat No D of C* CLIA Letter
QuickVue In-Line Strep A 00343 18KB 38KB
QuickVue+ Strep A 20122 18KB 19KB
QuickVue Dipstick Strep A 20108 39KB 31KB
QuickVue Dipstick Strep A 20125    
QuickVue Dipstick Strep A Sampler 20163
 

Pregnancy
Name Cat No D of C* CLIA Letter
QuickVue+ One-Step hCG Combo (W) 00178 17KB 25KB
QuickVue+ One-Step hCG Combo (MC) 00178    
QuickVue+ One-Step hCG Combo (W) 00179   25KB
QuickVue+ One-Step hCG Combo (MC) 00179    
QuickVue One-Step hCG Urine 20109 19KB 35KB
QuickVue One-Step hCG Combo (W) 20110 18KB 38KB
QuickVue One-Step hCG Combo (MC) 20110
18KB

H. pylori
Name Cat No D of C* CLIA Letter
QuickVue H. pylori gII (W) 0W009 36KB 44KB
QuickVue H. pylori gII (MC) 0W009
44KB
QuickVue H. pylori gII (W) 0W010
66KB
QuickVue H. pylori gII (MC) 0W010
44KB

Influenza
Name Cat No D of C* CLIA Letter
QuickVue Influenza 00317 36KB 36KB
QuickVue Influenza A+B 20183 16KB 15KB
QuickVue Influenza A+B Sampler 20185  

RSV
Name Cat No D of C* CLIA Letter
QuickVue RSV 20193 236KB
64KB
QuickVue RSV Sampler 20199
 

Bone Markers
Name Cat No D of C* CLIA Letter
MicroVue Osteocalcin 8002 25KB
MicroVue CICP 8003 32KB
MicroVue DPD 8007 31KB
MicroVue PYD 8010 26KB
MicroVue BAP 8012 30KB
MicroVue TRAP5b EIA Kit 8036 45KB  
MicroVue Calcitonin 8043 27KB  
MicroVue Intact PTH 8044 28KB
Autoimmune & Complement
Name Cat No D of C* CLIA Letter
MicroVue CIC-C1q EIA A001 25KB  
MicroVue CIC-C1q Controls A013 26KB  
MicroVue CIC-Raji Cell Replacement EIA (CIC-C3d EIA) A002 27KB  
MicroVue C1 Inhibitor EIA A003 24KB  
MicroVue C4d EIA Kit A008 26KB  
MicroVue C3a Plus EIA Kit A032 24KB  
MicroVue C5a EIA Kit A025 24KB  
MicroVue Bb Plus EIA Kit A027 24KB  
MicroVue CH50 Eq EIA Kit A018 25KB  
MicroVue SC5b-9 Plus EIA Kit A029 35KB  
MicroVue Ba EIA Kit A034 29KB  
MicroVue C4a EIA Kit A036 30KB  
MicroVue C1 Inhibitor Plus EIA Kit A037 26KB  
* D of C is the European Declaration of Conformity

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