AccessGUDID - DEVICE: BinaxNOW® Malaria (10811877010378)

GUDID

Device Identifier (DI) Information

Brand Name: BinaxNOW® Malaria
Version or Model: 665-025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Alere Scarborough, Inc.

Primary DI Number: 10811877010378
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154148498 *Terms of Use

Device Description: For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.

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:	Yes
Prescription Use (Rx):	No
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?
52311	Multiple Plasmodium species antigen 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 antigens from multiple species of Plasmodium, the malaria parasites (e.g., P. falciparum, P. vivax, P. ovale, P. knowlesi, P. malariae), 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAX	Plasmodium Spp. Detection Reagents

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN070006	000

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: 5f48d5a5-fd16-4e04-aadf-7af29a3b48ff
Public Version Date: September 12, 2023
Public Version Number: 5
DI Record Publish Date: September 03, 2016