Optilite Alpha-1-antitrypsin Kit

Basic Information

• Brand Name: Optilite Alpha-1-antitrypsin Kit
• Primary DI: 05051700017763
• Version / Model: NK034.OPT.A
• Company Name: THE BINDING SITE GROUP LIMITED
• Labeler DUNS: 347045614
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a6b3e0e1-8692-47f1-b7d4-6a9d4c21303b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	866.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53602	Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-1-antitrypsin (protease inhibitor) in a clinical specimen, using a nephelometry/turbidimetry method. Alpha-1-antitrypsin deficiency is typically associated with liver cirrhosis and pulmonary emphysema.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051700017763	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123256	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius