QuickVue 20201
GUDID 30014613202011
QuickVue iFOB Tray Pack 50T
QUIDEL CORPORATION
Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 30014613202011 |
| NIH Device Record Key | f7d43a0e-e75c-4c56-93c3-36e620b4cdf7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QuickVue |
| Version Model Number | iFOB Test |
| Catalog Number | 20201 |
| Company DUNS | 079509836 |
| Company Name | QUIDEL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30014613202011 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K021423
FDA Product Code
| KHE | REAGENT, OCCULT BLOOD |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [QuickVue]
| 30014613003175 | QkVue Flu Bulk 25T |
| 30014613331452 | QkVue Strep A Dpstk, 4T Samp |
| 30014613320104 | QkVue H pylori gII 30T |
| 30014613320098 | QkVue H pylori gII 10T |
| 30014613202226 | QkVue RSV 10, 25T |
| 30014613202059 | QuickVue iFOB Test Dev Kit 100T |
| 30014613202042 | QuickVue iFOB Collect Kit 40T |
| 30014613202011 | QuickVue iFOB Tray Pack 50T |
| 30014613201960 | QuickVue iFOB Collect Kit 10T |
| 30014613201946 | QuickVue iFOB 20T |
| 30014613201939 | QkVue RSV 20T |
| 30014613201830 | QkVue Flu A+B 25T, CE |
| 30014613201526 | QkVue Strep A Dpstk 10T |
| 30014613201250 | QkVue Strep A Dpstk 25T |
| 30014613201120 | RpdVue hCG 25T |
| 30014613201106 | QkVue HCG Combo, 50T |
| 30014613201090 | QkVue hCG Urine 25T |
| 30014613201083 | QkVue Strep A Dpstk 50T |
| 30014613200062 | QkVue Chlamydia 25T |
| 30014613003540 | Strep A Liquid Ctrl |
| 30014613002819 | hCG Ctrl Set - Serum |
| 30014613002727 | hCG Ctrl Set - Urine |
| 30014613331469 | QkVue Flu A+B 20K-T, Bulk |
| 30014613201977 | QkVue iFOB Control Set |
| 30014613339373 | QuickVue® SARS Antigen Test |
| 30014613339724 | QuickVue At-Home OTC COVID-19 Test |
| 30014613339687 | QuickVue At-Home OTC COVID-19 Test |
| 30014613339670 | QuickVue At-Home OTC COVID-19 Test |
Trademark Results [QuickVue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUICKVUE 78300520 not registered Dead/Abandoned |
Galaxy Power, Inc. 2003-09-15 |
 QUICKVUE 77835228 4191009 Live/Registered |
SKYHAWKE TECHNOLOGIES, LLC 2009-09-25 |
 QUICKVUE 77267312 3426296 Live/Registered |
Quidel Corporation 2007-08-29 |
 QUICKVUE 76309212 not registered Dead/Abandoned |
CASTLEDEX Business Systems Pty Ltd 2001-09-06 |
 QUICKVUE 76108596 not registered Dead/Abandoned |
Locale Systems Corporation 2000-08-14 |
 QUICKVUE 74801126 1777007 Dead/Cancelled |
QUIDEL CORPORATION 1991-10-29 |
 QUICKVUE 74716332 not registered Dead/Abandoned |
QUIDEL CORPORATION 1995-08-16 |
 QUICKVUE 74420584 1879570 Dead/Cancelled |
Optical Radiation Corporation 1993-08-02 |
 QUICKVUE 74216840 not registered Dead/Abandoned |
QUIDEL CORPORATION 1991-10-29 |
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