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  |
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| 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 |
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| Name | Cat No | D of C* | CLIA Letter |
| QuickVue+ Infectious Mononucleosis (Whole Blood/Serum/Plasma) (W) |
20121 | 19KB | 20KB |
| Strep A |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Name | Cat No | D of C* | CLIA Letter |
| QuickVue RSV | 20193 | 236KB |
35KB |
| Infectious Vaginitis |
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| 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 |
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| 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 |
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