BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit 256041
GUDID 00382902560418
BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit Contains: 30 each, Flu A+B Device, RV Reagent C unitized tubes, Flu A+/B- Control Swabs, Flu B+/A- Control Swabs.
BECTON, DICKINSON AND COMPANY
Influenza/parainfluenza virus antigen IVD, kit, immunochromatographic test (ICT), rapid| Primary Device ID | 00382902560418 |
| NIH Device Record Key | 394f0e76-574e-4a22-80e1-4c019a6d09ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD Veritor™ System For Rapid Detection of Flu A+B Laboratory kit |
| Version Model Number | 256041 |
| Catalog Number | 256041 |
| Company DUNS | 122561087 |
| Company Name | BECTON, DICKINSON AND COMPANY |
| 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 | false |
| 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
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com | |
| Phone | +1(800)638-8663 |
| Technical_services@bd.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382902560418 [Primary] |
| GS1 | 05032902560417 [Package] Package: Case [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K120049
FDA Product Code
| GNX | ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C |
| PSZ | Devices detecting influenza A, B, and C virus antigens |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-02 |
Devices Manufactured by BECTON, DICKINSON AND COMPANY
| 50382903032780 - Eclipse Needle | 2024-11-21 NEEDLE ECLIPSE 23X1-1/2 RB TW BNS |
| 60382904454755 - BD BACTEC™ 9240 | 2024-11-12 BD BACTEC™ 9240 |
| 60382904455707 - BD BACTEC™ 9120 | 2024-11-12 BD BACTEC™ 9120 |
| 00382904458003 - BD BACTEC™ 9050 | 2024-11-11 BD BACTEC™ 9050 |
| 00382904454166 - BD Onclarity HPV Self Collection Diluent Tube | 2024-11-11 BD Onclarity HPV Self Collection Diluent Tube |
| 00382906639844 - Horizon | 2024-10-22 CD138 (MI15) BV421 ASR |
| 00382906651204 - Horizon | 2024-10-22 CD197 (2-L1-A) APC-R700 ASR |
| 00382906651297 - Horizon | 2024-10-22 CD194 (1G1) BV421 ASR |
Trademark Results [BD Veritor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD VERITOR 85051782 4099717 Live/Registered |
Becton, Dickinson and Company 2010-06-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.