AccessGUDID - DEVICE: Total Thyroxine (T4) ELISA (00840239017819)

GUDID

Device Identifier (DI) Information

Brand Name: Total Thyroxine (T4) ELISA
Version or Model: EIA-1781
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EIA-1781
Company Name: DRG International Inc

Primary DI Number: 00840239017819
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 075150847 *Terms of Use

Device Description: For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
61252	Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple thyroid markers associated with thyroid disease in a clinical specimen using an enzyme immunoassay (EIA) method. Analytes detected may include, but are not limited to, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH) and/or thyroid peroxidase (TPO).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLI	Enzyme immunoassay, non-radiolabeled, total thyroxine

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
Device Size Text, specify: Conjugate Diluent
Total Volume: 11 Milliliter
Device Size Text, specify: TMB
Device Size Text, specify: Stop Solution
Device Size Text, specify: Standards
Total Volume: 13 Milliliter
Device Size Text, specify: Conjugate Concentrate
Total Volume: 1.3 Milliliter
Total Volume: 1 Milliliter

Device Record Status

Public Device Record Key: d66e8c5f-835d-4093-a012-28c23616f611
Public Version Date: August 16, 2023
Public Version Number: 4
DI Record Publish Date: March 20, 2019