BD Onclarity™ HPV Assay Reagent Pack 444075
GUDID 00382904440756
Kit HPV Assay Reagent for BD COR US
BECTON, DICKINSON AND COMPANY
Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 00382904440756 |
| NIH Device Record Key | 6bc1e4b5-19fe-4b00-a5c3-49707fcedb06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD Onclarity™ HPV Assay Reagent Pack |
| Version Model Number | 444075 |
| Catalog Number | 444075 |
| 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 | 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
| 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 33 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 33 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382904440756 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160037
FDA Product Code
| MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-07 |
| Device Publish Date | 2024-04-29 |
Devices Manufactured by BECTON, DICKINSON AND COMPANY
| 00382906651266 - N/A | 2024-05-17 BD® FoxP3 (236A/E7) PerCP-Cy5.5 |
| 00382904440756 - BD Onclarity™ HPV Assay Reagent Pack | 2024-05-07Kit HPV Assay Reagent for BD COR US |
| 00382904440756 - BD Onclarity™ HPV Assay Reagent Pack | 2024-05-07 Kit HPV Assay Reagent for BD COR US |
| 00382906635419 - N/A | 2024-04-29 BD® CD23 (EBVCS-5) PE-Cy7 |
| 00382903050284 - BD Sharps Collector | 2024-04-26 SHARPS COLL 17GAL HINGE PHARWASTE |
| 00382903050536 - BD Recykleen™ Sharps Collector | 2024-04-26 SHARPS COLL 3GAL RECYKLEEN PEARL |
| 00382903050543 - BD Recykleen™ Sharps Collector | 2024-04-26 SHARPS COLL 3GAL RECYKLEEN RED |
| 00382903050581 - BD Recykleen™ Sharps Collector | 2024-04-26 SHARPS COLL NEXT GEN 5.4QT PHARM RECYK |
| 00382903050765 - BD Sharps Collector | 2024-04-26 SHARPS COLL CHEMO 3GAL YELLOW NEW CAP |
Trademark Results [BD Onclarity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD ONCLARITY 87248678 5649839 Live/Registered |
Becton, Dickinson and Company 2016-11-28 |
 BD ONCLARITY 85917455 not registered Dead/Abandoned |
Becton, Dickinson and Company 2013-04-29 |
 BD ONCLARITY 85236664 not registered Dead/Abandoned |
Becton, Dickinson and Company 2011-02-08 |
 BD ONCLARITY 85236650 not registered Dead/Abandoned |
Becton, Dickinson and Company 2011-02-08 |
 BD ONCLARITY 85236642 not registered Dead/Abandoned |
Becton, Dickinson and Company 2011-02-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.