AccessGUDID - DEVICE: BioArray Assay Imaging System TM (AIS) 400C (10888234102212)

GUDID

Device Identifier (DI) Information

Brand Name: BioArray Assay Imaging System TM (AIS) 400C
Version or Model: 790-20006-RF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 790-20006-RF
Company Name: BIOARRAY SOLUTIONS LTD

Primary DI Number: 10888234102212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 949103725 *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):	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?
57852	Microarray analyser IVD, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the in vitro determination of multiple target analytes in a single clinical specimen using oligonucleotide capture molecules arranged in a consistent pattern on a slide, chip or membrane. Identification of a target sequence in the clinical specimen is by hybridization of complementary base pairs, with a detection system typically using fluorophores, fluorescent-labelled dyes, and/or digital imaging techniques. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NSU	Instrumentation For Clinical Multiplex Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK130051	0

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: Avoid exposure to direct sunlight
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Temperature of 15 degrees Celsius to 26.7 degrees Celsius when in use

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7db432e8-6c45-4d36-a7c7-d16bf1b99460
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 28, 2015