AccessGUDID - DEVICE: IMMULITE® 2000 Systems TU Thyroid Uptake (00630414962207)

GUDID

Device Identifier (DI) Information

Brand Name: IMMULITE® 2000 Systems TU Thyroid Uptake
Version or Model: 10381669
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L2KTU2
Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Primary DI Number: 00630414962207
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 296822794 *Terms of Use

Device Description: T Uptake - IMMULITE - RGT - 200 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?
54397	Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the unbound/free portion of multiple proteins [e.g., thyroxine binding globulin (TBG), transthyretin and/or albumin] associated with thyroid hormone uptake, in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid in the assessment of thyroid hormone binding capacity for the diagnosis of thyroid disorders associated with hypothyroidism or hyperthyroidism.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEE	Radioimmunoassay, thyroxine-binding globulin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K910677	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: aecb0102-ae40-430c-8a72-c5adcd1b52bd
Public Version Date: February 05, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016