AccessGUDID - DEVICE: Fast 96-Well Spectral Calibration Plate with ROX™ Dye (10190302000390)

GUDID

Device Identifier (DI) Information

Brand Name: Fast 96-Well Spectral Calibration Plate with ROX™ Dye
Version or Model: 4432614
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFE TECHNOLOGIES HOLDINGS PTE. LTD.

Primary DI Number: 10190302000390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 628548377 *Terms of Use

Device Description: FAST 96W CALIBRATION ROX IVD

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):	Yes
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?
61303	Thermal cycler nucleic acid instrument calibrator/control kit IVD	A collection of reagents and other associated materials of known characteristics intended to be used to calibrate or verify the performance of a thermal cycler nucleic acid instrument/analyser [e.g., real-time polymerase chain reaction (PCR) machine] to ensure its proper function prior to analysis/processing of clinical samples.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOI	real time Nucleic acid amplification system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123955	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c6b1d7ec-cfba-44fb-9dc7-c8ed06118767
Public Version Date: February 06, 2025
Public Version Number: 9
DI Record Publish Date: August 01, 2016