AccessGUDID - DEVICE: ASI Sickle Cell Test (00816057020003)

GUDID

Device Identifier (DI) Information

Brand Name: ASI Sickle Cell Test
Version or Model: NC-200025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NC-200025
Company Name: ARLINGTON SCIENTIFIC, INC.

Primary DI Number: 00816057020003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785966607 *Terms of Use

Device Description: Detection of presence of Hgb-S

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:	Yes
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?
55906	Haemoglobin S (HbS) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of haemoglobin subtype S (HbS), also known as sickle cell haemoglobin, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GHM	Test, Sickle Cell

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
Storage Environment Temperature: between 20 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 25 Test

Device Record Status

Public Device Record Key: 0add7dda-92d8-482a-8b15-f6fe3564878c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 08, 2016