BinaxNOW Streptococcus pneumoniae Antigen Card

GUDID 10811877011061

The BinaxNOW Streptococcus pneumoniae Antigen Card is an in vitro rapid immunochromatographic assay for the detection of Streptococcus pneumoniae antigen in the urine of patients with pneumonia and in the cerebral spinal fluid of patients with meningitis.

Alere Scarborough, Inc.

Streptococcus pneumoniae antigen IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10811877011061
• NIH Device Record Key: 7c1e7b32-03a6-4d56-b3d4-6288b23dff48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW Streptococcus pneumoniae Antigen Card
• Version Model Number: 710-000
• Company DUNS: 154148498
• Company Name: Alere Scarborough, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877011061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012521

FDA Product Code

• GTZ: Antisera, All Groups, Streptococcus Spp.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-24
• Device Publish Date: 2020-09-16

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