AccessGUDID - DEVICE: Free T4 MAb 125I RIA Kit (00817830022504)

GUDID

Device Identifier (DI) Information

Brand Name: Free T4 MAb 125I RIA Kit
Version or Model: 06B257215
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06B257215
Company Name: MP BIOMEDICALS, LLC

Primary DI Number: 00817830022504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137825928 *Terms of Use

Device Description: Radioimmunoassay for the quantitative determination of Free Thyroxine (T4) in human plasma or serum.

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?
54411	Free thyroxine (FT4) IVD, kit, radioimmunoassay	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 radioimmunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEC	RADIOIMMUNOASSAY, FREE THYROXINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K823264	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
Length: 23 Centimeter

Device Record Status

Public Device Record Key: 806f9292-a00f-458a-9a5d-adcfb3ac9cc0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 20, 2016