AccessGUDID - DEVICE: IMMULITE® Systems TG Recovery Sample Thyroglobulin (00630414954523)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® Systems TG Recovery Sample Thyroglobulin
Version or Model: 10381639
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LTYRM
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414954523
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: Thyreoglobulin Recovery Sample - IMMULITE - CONS - 80 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?
54376	Thyroglobulin IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of thyroglobulin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSW	System,test,thyroglobulin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982466	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: 245f76f9-7ce6-4478-8cfc-ed252acf4cd4
Public Version Date: January 12, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016