ACON SARS-CoV-2 IgG/IgM Rapid Test

Basic Information

• Brand Name: ACON SARS-CoV-2 IgG/IgM Rapid Test
• Primary DI: 00682607200979
• Version / Model: L031-11711
• Catalog Number: 200979
• Company Name: ACON LABORATORIES, INC.
• Labeler DUNS: 781100966
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2021-02-08
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6244f1ab-86ac-4a61-ae08-470358c4c934

Device Description

Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• 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
QKO	Reagent, coronavirus serological	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
64756	SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20682607200973	GS1	Carton	45	In Commercial Distribution
Primary	00682607200979	GS1
Unit of Use	00682607002269	GS1

Customer Contacts

• Phone: [phone] ext. 1
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: The kit can be stored at room temperature or refrigerated (2-30°C). The test is stable until the expiration date printed on the sealed pouch. Do not freeze.