AccessGUDID - DEVICE: TLiIQ System (25420045500874)

GUDID

Device Identifier (DI) Information

Brand Name: TLiIQ System
Version or Model: TLiIQ System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01202
Company Name: Hologic, Inc.

Primary DI Number: 25420045500874
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 018925968 *Terms of Use

Device Description: System that detects fFN in cervicovaginal secretions.

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:	Yes
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	006
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
Handling Environment Humidity: between 50 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 18 and 30 Degrees Celsius
Handling Environment Temperature: between 18 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6020f1f8-fc11-433d-8785-fce615105dc2
Public Version Date: August 15, 2024
Public Version Number: 1
DI Record Publish Date: August 07, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)442-9892
Email: CustomerSupport@hologic.com

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