AccessGUDID - DEVICE: IMMULITE® 2000 TSI (00630414597188)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® 2000 TSI
Version or Model: 10876421
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L2KSI2(D)
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414597188
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: IMMULITE(R) 2000 TSI Assay

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?
54393	Thyroid stimulating hormone receptor (TSHR) 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 stimulating hormone receptor (TSHR), also known as thyrotropin receptor, in a clinical specimen using a chemiluminescent immunoassay method. It is used in the diagnosis of autoimmune thyroid disorders such as hyperthyroidism in Graves’ disease.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZO	SYSTEM, TEST, THYROID AUTOANTIBODY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152061	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: 4a91b599-bba0-4d44-aa7f-7b8c9e417330
Public Version Date: November 18, 2021
Public Version Number: 6
DI Record Publish Date: September 24, 2016