AccessGUDID - DEVICE: Total T3 125I RIA Kit (00817830022450)

GUDID

Device Identifier (DI) Information

Brand Name: Total T3 125I RIA Kit
Version or Model: 06B254216
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06B254216
Company Name: MP BIOMEDICALS, LLC

Primary DI Number: 00817830022450
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 triiodothyronine (T3) in 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?
54420	Reverse triiodothyronine (reverse T3) IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of reverse triiodothyronine (reverse T3) in a clinical specimen, using a radioimmunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDP	RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 4f5ff4f9-7c33-4af2-a056-c94051e0cffb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 20, 2016