Aptima® ASY-16708
GUDID 15420045517073
Aptima® CV/TV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis.
Hologic, Inc.
Multiple-type vaginitis-associated organism nucleic acid IVD, kit, nucleic acid technique (NAT)| Primary Device ID | 15420045517073 |
| NIH Device Record Key | 28e93d64-004e-46bd-9e8f-a621b07a3a9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aptima® |
| Version Model Number | KIT, BOX 1, REFRIGERATED, ACV/TV, 250T, IVD |
| Catalog Number | ASY-16708 |
| Company DUNS | 050579217 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045517073 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K243345
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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-27 |
| Device Publish Date | 2024-12-19 |
On-Brand Devices [Aptima®]
| 15420045511880 | Aptima® Specimen Transfer Kit, 100 test. |
| 15420045517134 | Aptima® Whole Blood Diluent, 100 tubes. |
| 15420045517080 | Aptima® CV/TV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an |
| 15420045517073 | Aptima® CV/TV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® CV/TV assay is an in |
| 15420045517066 | Aptima® BV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vit |
| 15420045517059 | Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro |
| 15420045517035 | Aptima® SARS-CoV-2 Assay Controls Kit. |
| 15420045517004 | Aptima® SARS-CoV-2 Assay, 100 test, box 2 of 2 (15°C to 30°C box). |
| 15420045516991 | Aptima® SARS-CoV-2 Assay, 100 test, box 1 of 2 (2°C to 8°C box). |
Trademark Results [Aptima]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APTIMA 90871221 not registered Live/Pending |
Aptima, Inc. 2021-08-08 |
 APTIMA 78315970 2884471 Live/Registered |
Gen-Probe Incorporated 2003-10-20 |
 APTIMA 78151859 2840053 Live/Registered |
Gen-Probe Incorporated 2002-08-07 |
 APTIMA 77975375 3530982 Live/Registered |
Aptima, Inc. 2007-08-29 |
 APTIMA 77267375 3405210 Live/Registered |
Aptima, Inc. 2007-08-29 |
 APTIMA 77267356 not registered Dead/Abandoned |
Aptima, Inc. 2007-08-29 |
 APTIMA 76031168 2440995 Live/Registered |
Aptima, Inc. 2000-04-18 |
 APTIMA 75588396 2432113 Live/Registered |
Gen-Probe Incorporated 1998-11-13 |
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