BD MAX ™ 443420
GUDID 30382904434206
BD MAX ™ UVE Sample Buffer Tubes Contains: 48 x 1.5 mL Sample Buffer
Geneohm Sciences Canada Inc
Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 30382904434206 |
| NIH Device Record Key | c592a1f8-9bba-4045-b43d-7f257b20a6f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD MAX ™ |
| Version Model Number | 443420 |
| Catalog Number | 443420 |
| Company DUNS | 255438483 |
| Company Name | Geneohm Sciences Canada Inc |
| Device Count | 48 |
| 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 |
Device Dimensions
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
| Total Volume | 1.5 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382904434205 [Unit of Use] |
| GS1 | 30382904434206 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151589
FDA Product Code
| OUY | Trichomonas vaginalis nucleic acid amplification test system |
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 | 2016-10-17 |
Devices Manufactured by Geneohm Sciences Canada Inc
| 00382904438128 - BD MAX™ Extended Enteric Bacterial Panel | 2019-02-04 BD MAX™ Extended Enteric Bacterial Panel |
| 30382904375196 - BD MAX™ PCR Cartridge | 2019-01-23 Cartridge BD Max PCR 24 EA |
| 00382904416379 - BD GeneOhm™ MRSA ACP Assay (48 tests) | 2019-01-23 BD GeneOhm™ MRSA ACP Assay (48 tests) |
| 00382904416386 - BD GeneOhm™ MRSA ACP Lysis Kit | 2019-01-23 BD GeneOhm™ MRSA ACP Lysis Kit |
| 00382904416393 - BD GeneOhm™ MRSA ACP Assay | 2019-01-23 BD GeneOhm™ MRSA ACP Assay (200 tests) |
| 00382904429539 - BD MAX™ MRSA | 2019-01-23 BD MAX™ MRSA |
| 00382904434618 - BD MAX™ MRSA XT | 2019-01-23 BD MAX™ MRSA XT Contains 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer Tubes, 25 Septum Caps, 24 Strips Cont |
| 30382904433766 - BD MAX™ UVE Specimen Collection Kit | 2018-07-06 BD MAX™ UVE Specimen Collection Kit Contains: 100 each Sterile polyester-tipped collector swab, transfer pipette, UVE Sample b |
Trademark Results [BD MAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BD MAX 88922910 not registered Live/Pending |
Becton, Dickinson and Company 2020-05-19 |
 BD MAX 77749086 3931753 Live/Registered |
BECTON DICKINSON INFUSION THERAPY SYSTEM 2009-06-01 |
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