AccessGUDID - DEVICE: FastPack® IP TSH Kit (30) (20816467020086)

GUDID

Device Identifier (DI) Information

Brand Name: FastPack® IP TSH Kit (30)
Version or Model: TSH Immunoassay
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 25000042
Company Name: QUALIGEN INC.

Primary DI Number: 20816467020086
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 TSH 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?
54386	Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen, using a chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101390	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: 9ab6e284-a393-42bd-9763-dd7d5a5f06ac
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016