ASI Sickle Cell Test

Basic Information

• Brand Name: ASI Sickle Cell Test
• Primary DI: 00816057020034
• Version / Model: NC-200100E
• Catalog Number: NC-200100E
• Company Name: ARLINGTON SCIENTIFIC, INC.
• Labeler DUNS: 785966607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-08
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 88a28afe-3ccb-42ca-b024-62b1927c9a5d

Device Description

Detection of the presence of Hgb-S, Export

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GHM	Test, Sickle Cell	Hematology	864.7825	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816057020034	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			100 Test

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius