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 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 15420045516694 [Unit of Use] |
GS1 | 25420045516691 [Primary] |
QOF | Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-22 |
Device Publish Date | 2023-08-14 |
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15420045516212 - Fluent Pro Fluid Management System | 2024-08-14 The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hy |
15420045510470 - Panther Fusion® | 2024-07-22 Panther Fusion® Internal Control-X. |
15420045510890 - Panther Fusion® | 2024-07-22 The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing realtime PCR for detection of Grou |
15420045510548 - 3Dimensions | 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
15420045510555 - 3Dimensions | 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
15420045510562 - 3Dimensions | 2024-07-08 Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray image |
15420045510579 - 3Dimensions | 2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() RESPDIRECT 98525223 not registered Live/Pending |
Gen-Probe Incorporated 2024-04-29 |