ID NOW COVID-19 2.0 Control Swab Kit

Basic Information

• Brand Name: ID NOW COVID-19 2.0 Control Swab Kit
• Primary DI: 00811877011361
• Version / Model: 192-080
• Company Name: Alere Scarborough, Inc.
• Labeler DUNS: 154148498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-09
• Public Version: 2
• Public Version Date: 2023-09-14
• Public Version Status: Update
• Public Device Record Key: c2bd1acc-dcab-45df-b5b6-ae731f69ce90

Device Description

Control Swabs intended for use only with the ID NOW™ COVID-19 2.0 product. Refer to the ID NOW COVID-19 2.0 Product Insert for instructions for use.

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: 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
QWR	Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings	Microbiology	866.3982	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64748	SARS-CoV-2 nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent for COVID-19, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811877011361	GS1

Premarket Submissions

Submission Number	Supplement Number
K221925	000