BinaxNOW® G6PD

GUDID 10811877010705

For the qualitative detection of G6PD enzyme activity in blood.

Alere Scarborough, Inc.

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, rapid ICT, clinical

• Primary Device ID: 10811877010705
• NIH Device Record Key: 43782341-ea3c-45e5-a6ee-24ac7ec86662
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BinaxNOW® G6PD
• Version Model Number: 780-000
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877010705 [Primary]

FDA Product Code

• JBF: Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-03

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