AccessGUDID - DEVICE: ASiManager-AT (00816057020041)

GUDID

Device Identifier (DI) Information

Brand Name: ASiManager-AT
Version or Model: NC-2400-0BT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NC-2400-0BT
Company Name: ARLINGTON SCIENTIFIC, INC.

Primary DI Number: 00816057020041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785966607 *Terms of Use

Device Description: Semi-automated reader for RPR testomg

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?
57863	Microplate reader IVD, manual	An electrically-powered manual laboratory instrument intended to be used to photometrically measure the optical absorbance or emission of clinical specimens in microplates containing multiple individual sample wells, with or without a separate cuvette-reading station. The device utilizes technology which may include reagent dispensing, a single or dual lightsource, bandpass filters, monochromators, photodetectors, data processing software and/or data displays to determine the qualitative and/or quantitative values of biological constituents of a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQT	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

FDA Premarket Submission

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

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: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 1.24 Square meter

Device Record Status

Public Device Record Key: efcef82c-cac1-4bc9-ab2d-17bf3383baa6
Public Version Date: September 16, 2022
Public Version Number: 3
DI Record Publish Date: July 08, 2016