Rapid fFN® 01200
GUDID 25420045501154
Rapid fFN® test cassettes for the TLI IQ® system, 26 count.
Hologic, Inc.
Fibronectin IVD, kit, enzyme immunohistochemistry| Primary Device ID | 25420045501154 |
| NIH Device Record Key | fde96a4c-d9b7-4786-a33b-334da66dce2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rapid fFN® |
| Version Model Number | KIT, RAPID FFN 26 CASSETTE TLIIQ SYSTEM |
| Catalog Number | 01200 |
| Company DUNS | 050579217 |
| Company Name | Hologic, Inc. |
| Device Count | 26 |
| 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 | 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)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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045501157 [Unit of Use] |
| GS1 | 25420045501154 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P920048
FDA Product Code
| LKV | ENZYME IMMUNOASSAY, FETAL FIBRONECTIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-06-13 |
| Device Publish Date | 2014-08-18 |
Devices Manufactured by Hologic, Inc.
| 15420045510524 - 3Dimensions | 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
| 15420045510616 - Selenia Dimensions | 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
| 15420045510753 - Selenia Dimensions | 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
| 15420045510777 - Selenia Dimensions | 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
| 15420045510784 - Selenia Dimensions | 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
| 15420045512641 - Dimensions | 2024-09-23 Contrast Enhanced Digital Mammography Imaging Kit |
| 15420045512658 - I-View | 2024-09-23 |
| 15420045512665 - I-View | 2024-09-23 |
Trademark Results [Rapid fFN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RAPID FFN 77840300 3781153 Live/Registered |
Hologic, Inc. 2009-10-02 |
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