Autostat II Anti-MPO

Basic Information

• Brand Name: Autostat II Anti-MPO
• Primary DI: 00816879020120
• Version / Model: FGA12
• Company Name: HYCOR BIOMEDICAL LLC
• Labeler DUNS: 010558476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 4c468ee4-b4f8-4c3b-a93d-c038682ecb49

Device Description

96 well ELISA for the detection of anti-MPO antibodies in human serum

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55068	Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-neutrophil cytoplasmic antibodies (ANCA) to myeloperoxidase (MPO) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816879020120	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K002215	000

Storage Conditions

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