AccessGUDID - DEVICE: FastPack® IP Free T4 Kit (30) (20816467020055)

GUDID

Device Identifier (DI) Information

Brand Name: FastPack® IP Free T4 Kit (30)
Version or Model: FT4 Immunoassay
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25000043
Company Name: QUALIGEN INC.

Primary DI Number: 20816467020055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 959103565 *Terms of Use

Device Description: 30 Test Ported FT4 Immunoassay Kit

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:	Yes
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?
54413	Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of free thyroxine (FT4) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEC	Radioimmunoassay, Free Thyroxine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030329	000

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: c227ff94-a995-487d-90be-2c9ef0223055
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016