ISOSTAT® Consumables

GUDID 10811877010064

Consumables needed for processing ISOLATOR 10 mL Microbial Tubes for adults.

Alere Scarborough, Inc.

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• Primary Device ID: 10811877010064
• NIH Device Record Key: 7d27aebf-f32a-4304-a515-65956943dc5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISOSTAT® Consumables
• Version Model Number: 50C9
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877010064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K840496

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-19
• Device Publish Date: 2016-09-05

Devices Manufactured by Alere Scarborough, Inc.

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• 10811877010637 - Alere NMP22® Urine Collection Kit: 2023-09-14 The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will b
• 10811877010798 - DIGIVAL Calibration Check Card Pack: 2023-09-14 A calibration check card verifies that the DIGIVAL is functioning correctly
• 00811877011477 - BinaxNOW COVID-19 Antigen Self Test: 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011507 - BinaxNOW COVID-19 Antigen Self Test: 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011798 - BinaxNOW COVID-19 Antigen Self Test: 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 10811877010019 - Alere i Influenza A & B 2: 2023-09-12 A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimen