RESPDIRECT™ PRD-07788
GUDID 15420045516694
RespDirect™ Collection Kit, 50 count.
Hologic, Inc.
Oral/upper respiratory tract specimen collection kit IVD, clinical| Primary Device ID | 15420045516694 |
| NIH Device Record Key | 3132ba3a-df1b-4a37-ad25-a89d1960b228 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RESPDIRECT™ |
| Version Model Number | RESPDIRECT COLLECTION KIT, US-KIT, BOX |
| Catalog Number | PRD-07788 |
| Company DUNS | 050579217 |
| Company Name | Hologic, Inc. |
| Device Count | 50 |
| 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
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045516694 [Unit of Use] |
| GS1 | 25420045516691 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K222736
FDA Product Code
| QOF | Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents |
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 | 2023-08-22 |
| Device Publish Date | 2023-08-14 |
Devices Manufactured by Hologic, Inc.
| 15420045517059 - Aptima® | 2024-12-27 Aptima® BV assay, 250 test, box 1 of 2 (2°C to 8°C box). The Aptima® BV assay is an in vitro nucleic acid amplification test |
| 15420045517066 - Aptima® | 2024-12-27 Aptima® BV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® BV assay is an in vitro nucleic acid amplification te |
| 15420045517073 - Aptima® | 2024-12-27 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 amplificatio |
| 15420045517080 - Aptima® | 2024-12-27 Aptima® CV/TV assay, 250 test, box 2 of 2 (15°C to 30°C box). The Aptima® CV/TV assay is an in vitro nucleic acid amplificat |
| 15420045506411 - ATEC | 2024-10-24 |
| 15420045506428 - ATEC | 2024-10-24 |
| 15420045516144 - Fluent Pro Procedure Kit | 2024-10-23 The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hy |
| 15420045516113 - Fluent Pro Waste Bag | 2024-10-23 The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hy |
Trademark Results [RESPDIRECT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESPDIRECT 98525223 not registered Live/Pending |
Gen-Probe Incorporated 2024-04-29 |
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