AccessGUDID - DEVICE: Atellica IM T3/T4/VB12 ANC RGT (00630414599953)

GUDID

Device Identifier (DI) Information

Brand Name: Atellica IM T3/T4/VB12 ANC RGT
Version or Model: 10995682
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10995682
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414599953
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: T3/T4/VB12 Ancillary Reagent Atellica IM – CAL (2PK) 2 x 25mL

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?
61254	Multiple thyroid marker 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 qualitative and/or quantitative detection of multiple thyroid markers associated with thyroid disease in a clinical specimen. Analytes detected may include, but are not limited to free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH) and/or thyroid peroxidase (TPO).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDP	RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K913646	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
Special Storage Condition, Specify: Store upright
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: 8e928657-b2b3-4803-8e87-f5e265d31ed5
Public Version Date: June 09, 2023
Public Version Number: 6
DI Record Publish Date: February 06, 2018