AccessGUDID - DEVICE: Autostat II Anti-Thyroid Peroxidase (00816879020045)

GUDID

Device Identifier (DI) Information

Brand Name: Autostat II Anti-Thyroid Peroxidase
Version or Model: FGA04
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HYCOR BIOMEDICAL LLC

Primary DI Number: 00816879020045
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 010558476 *Terms of Use

Device Description: 96 well ELISA for the detection of anti-TPO antibodies in human 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):	No
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?
55203	Thyroid peroxidase antibody (anti-TPO/microsomal antibody) 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 antibodies to thyroid peroxidase [anti-TPO, also known as anti-microsomal antibody] in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of chronic lymphocytic thyroiditis (also known as hashimoto thyroiditis).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JNL	Immunochemical, Thyroglobulin Autoantibody

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: exactly 2 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d00ccef9-70d5-46e6-a644-010b14e78eb8
Public Version Date: September 06, 2024
Public Version Number: 6
DI Record Publish Date: September 26, 2016