AccessGUDID - DEVICE: ANAPLASTIC LYMPHOMA KINASE (ALK) (00810119679840)

GUDID

Device Identifier (DI) Information

Brand Name: ANAPLASTIC LYMPHOMA KINASE (ALK)
Version or Model: AY874-50D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AY874-50D
Company Name: BIOGENEX LABORATORIES

Primary DI Number: 00810119679840
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042697045 *Terms of Use

Device Description: No description.

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?
56791	Anaplastic lymphoma kinase IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of anaplastic lymphoma kinase, also known as ALK protein, CD246 or p80, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NJT	Immunohistochemistry Reagents And Kits

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
Special Storage Condition, Specify: 2-8°C

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: 70e31bb4-261c-4fa9-9ce8-5a11dfa85d19
Public Version Date: May 05, 2023
Public Version Number: 1
DI Record Publish Date: April 27, 2023