BD MAX™ Vaginal Panel 443712
GUDID 00382904437121
BD MAX™ Vaginal Panel Contains: 24 each Master Mix, Extraction Tubes, Strips containing Wash Buffer, Elution Buffer, Neutralization Buffer, 25 each Septum caps
Geneohm Sciences Canada Inc
Multiple vaginitis-associated organism nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 00382904437121 |
| NIH Device Record Key | 660689e2-9f12-4717-b93f-b0dbdbb8b152 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BD MAX™ Vaginal Panel |
| Version Model Number | 443712 |
| Catalog Number | 443712 |
| Company DUNS | 255438483 |
| Company Name | Geneohm Sciences Canada Inc |
| 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
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 |
| 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 | 00382904437121 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| NSU | Instrumentation For Clinical Multiplex Test Systems |
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 | 2017-03-23 |
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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