AccessGUDID - DEVICE: BinaxNOW COVID-19 Reagent Accessory Kit (00811877011576)

GUDID

Device Identifier (DI) Information

Brand Name: BinaxNOW COVID-19 Reagent Accessory Kit
Version or Model: 195-090
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alere Scarborough, Inc.

Primary DI Number: 00811877011576
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154148498 *Terms of Use

Device Description: Reagent Accessory Pack intended for use only with BinaxNOW™ COVID-19 product.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65148	SARS-CoV-2 antigen IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19, in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKP	Coronavirus Antigen Detection Test System.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 209220ef-f0a4-4407-be5c-9249e89c399e
Public Version Date: September 12, 2023
Public Version Number: 2
DI Record Publish Date: June 17, 2022