BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit 220143
GUDID 30382902201435
BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Collection Kit for Male Urethral Specimens, 100 units Contains: 100 each Sterile rayon-tipped Swab, CT/GC Diluent tubes
BECTON, DICKINSON AND COMPANY
General-purpose absorbent tip applicator/swab, single-use| Primary Device ID | 30382902201435 |
| NIH Device Record Key | 22992a56-8512-41e5-b5a7-b99a2a31b347 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit |
| Version Model Number | 220143 |
| Catalog Number | 220143 |
| 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 | |
| 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 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 |
| 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 | 00382902201434 [Primary] |
| GS1 | 30382902201435 [Package] Contains: 00382902201434 Package: Shelfpack [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K984631
FDA Product Code
| LSL | DNA-REAGENTS, NEISSERIA |
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 | 2019-11-08 |
| Device Publish Date | 2016-07-12 |
On-Brand Devices [BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit]
| 30382902201435 | BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Collec |
| 30382902201428 | BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Collec |
Trademark Results [BD ProbeTec]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD PROBETEC 78233570 2930549 Live/Registered |
Becton, Dickinson and Company 2003-04-03 |
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