AccessGUDID - DEVICE: IMMULITE®/IMMULITE® 1000 Systems ATA Anti -TPO Ab (00630414964744)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE®/IMMULITE® 1000 Systems ATA Anti -TPO Ab
Version or Model: 10381618
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LKTO1
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414964744
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: TPO Ab - IMMULITE - RGT - 100 Tests

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:	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?
58729	Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay	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 a chemiluminescent immunoassay 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
JZO	SYSTEM, TEST, THYROID AUTOANTIBODY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963695	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: 6a6628b6-872c-4f1d-9a1b-7df97cabd452
Public Version Date: February 16, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016