AccessGUDID - DEVICE: IMMULITE® 2000 Systems TG Thyroglobulin Sample Diluent (00630414954318)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® 2000 Systems TG Thyroglobulin Sample Diluent
Version or Model: 10387073
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L2TYZ
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414954318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: TG Ab Sample Diluent - IMMULITE - CAL - 1x25mL

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:	No
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?
52837	Multiple Schistosoma species immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to multiple species of the parasitic flatworm Schistosoma 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 [?]
K982468	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: ec0f3aa1-1025-4ce5-9a45-774add25b5c3
Public Version Date: June 02, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016