Fingerstick Sample Collection Kit

GUDID 00811877010395

Kit Intended to facilitate fingerstick whole blood sampling.

Alere Scarborough, Inc.

HIV1/HIV2 antigen/antibody IVD, reagent

• Primary Device ID: 00811877010395
• NIH Device Record Key: f293c336-e865-4dc7-8dd9-1c380d62aeb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fingerstick Sample Collection Kit
• Version Model Number: 2604US199
• 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	00811877010395 [Primary]

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: 2022-01-21
• Device Publish Date: 2022-01-13

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