AccessGUDID - DEVICE: Rapid fFN® (15420045501164)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid fFN®
Version or Model: KIT, RAPID FFN CONTROL TLIIQ SYSTEM, USA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01166
Company Name: Hologic, Inc.

Primary DI Number: 15420045501164
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: Rapid fFN® Control Kit (Rapid fFN® for the TLI IQ® System).

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57221	Fibronectin IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of fibronectin in a clinical specimen, using an enzyme immunohistochemistry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKV	ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P920048	001
P920048	002
P920048	003
P920048	005
P920048	009
P920048	011
P920048	013
P920048	019
P920048	024

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6fb30871-ccc6-42ad-937b-ade46eae4d88
Public Version Date: June 13, 2024
Public Version Number: 4
DI Record Publish Date: August 18, 2014