AccessGUDID - DEVICE: SureFISH 21q22.13 ERG 3p BA 426kb P5GRx6 (05700574025076)

GUDID

Device Identifier (DI) Information

Brand Name: SureFISH 21q22.13 ERG 3p BA 426kb P5GRx6
Version or Model: G210915G
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AGILENT TECHNOLOGIES, INC.

Primary DI Number: 05700574025076
Issuing Agency: GS1
Commercial Distribution End Date: May 11, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 084963177 *Terms of Use

Device Description: SureFISH 21q22.13 ERG 3p BA 426kb P5GRx6

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?
60120	Nucleic acid hybridization detection IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVU	Reagents, specific, analyte

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 -25 and -15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6 Tubes (5 µl)

Device Record Status

Public Device Record Key: 37d710f8-065a-4908-94a6-aaa80a281c6f
Public Version Date: June 10, 2024
Public Version Number: 2
DI Record Publish Date: May 10, 2022