APhL ELISA® IgG and IgM HRP Kit

Basic Information

• Brand Name: APhL ELISA® IgG and IgM HRP Kit
• Primary DI: B473LAPLKHRP00GM0
• Version / Model: IgG and IgM
• Catalog Number: LAPL-K-HRP-00GM
• Company Name: Louisville APL Diagnostics, Inc.
• Labeler DUNS: 018417647
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-06
• Public Version: 3
• Public Version Date: 2022-12-30
• Public Version Status: Update
• Public Device Record Key: f7678229-a8c3-4d09-a82f-8972b3648fef

Device Description

APhL ELISA® IgG and IgM HRP Kit For the Measurement of IgG and IgM Antiphospholipid Antibodies

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

GMDN Terms

Code	Name	Definition	Implantable	Status
55085	Phospholipid antibody 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 one or multiple antiphospholipid antibodies associated with antiphospholipid syndrome, 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	B473LAPLKHRP00GM0	HIBCC

Storage Conditions

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