AccessGUDID - DEVICE: IMMULITE® Systems TSH CONTROL Third Generation TSH (00630414953311)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® Systems TSH CONTROL Third Generation TSH
Version or Model: 10385395
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LTGCM
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414953311
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: TSH 3rd Gen - IMMULITE - CONS - 2x2.0mL

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?
38271	Thyroid stimulating hormone (TSH) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K930007	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: ad49c653-12b1-4d4e-b756-f1c41bf7c849
Public Version Date: November 18, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020