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
TUV Certificate - 13485 729KB
TUV EC Certificate for Chlamydia and Self Testing BlueTest 410KB
CMDCAS Certificate 153KB
Rapid Diagnostics
Chlamydia
Name Cat No D of C* CLIA Letter
QuickVue Chlamydia 0B006 20KB 22KB
QuickVue Chlamydia Sampler 0B008 20KB 22KB
QuickVue GmbH Chlamydia 0B009 20KB 22KB

Mononucleosis
Name Cat No D of C* CLIA Letter
QuickVue+ Infectious Mononucleosis
(Whole Blood/Serum/Plasma) (W)
20121 19KB 20KB

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 16KB 31KB
QuickVue Dipstick Strep A 20125 16KB 31KB
QuickVue Dipstick Strep A Sampler 4T 20163
31KB

Pregnancy
Name Cat No D of C* CLIA Letter
QuickVue+ One-Step hCG Combo 00178 17KB 25KB
QuickVue+ One-Step hCG Combo 00179 17KB 25KB
QuickVue One-Step hCG Urine 20109 19KB 35KB
QuickVue One-Step hCG Combo (W) 20110 18KB 36KB
QuickVue One-Step hCG Combo (MC) 20110
18KB
RapidVue hCG 00257 16KB 19KB

H. pylori
Name Cat No D of C* CLIA Letter
QuickVue H. pylori gII (W) 0W009 16KB 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 00324
36KB
QuickVue Influenza 00325 16KB
QuickVue Influenza A+B 20183 16KB
QuickVue Influenza A+B 20185 16KB

RSV
Name Cat No D of C* CLIA Letter
QuickVue RSV 20193 236KB
35KB

Infectious Vaginitis
Name Cat No D of C* CLIA Letter
 
QuickVue Advance G. vaginalis 20145 20KB 18KB
QuickVue Advance pH and Amines 20146
22KB
QuickVue Advance pH and Amines 20157 20KB 22KB
pH and Amines Controls 20147 20KB

Bone Markers
Name Cat No D of C* CLIA Letter
Metra Osteocalcin 8002 25KB
Metra CICP 8003 32KB
Metra DPD 8007 31KB
Metra PYD 8010 26KB
Metra BAP 8012 30KB
Autoimmune & Complement
Quidel CIC-C1q EIA A001 25KB
Quidel CIC-C1q Controls A013 26KB
Quidel CIC-Raji Cell Replacement EIA (CIC-C3d EIA) A002 27KB
Quidel CIC-Raji Cell Replacement Controls A014 26KB
Quidel C1 Inhibitor EIA A003 24KB
Quidel C4d EIA Kit A008 26KB
Quidel SC5b-9 EIA Kit A009 26KB
Quidel C3a EIA Kit A015 24KB
Quidel CH50 Eq EIA Kit A018 25KB
Quidel SC5b-9 Plus EIA Kit A029 35KB
* D of C is the European Declaration of Conformity

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