ISOLATOR™ 10 mL Microbial Tubes

GUDID 10811877010965

The ISOLATOR™ 10 mL Microbial Tubes is intended for use in the collection and concentration of mircroorganisms from the blood.

Alere Scarborough, Inc.

Blood cell lysis reagent IVD

• Primary Device ID: 10811877010965
• NIH Device Record Key: b36e2614-a7da-49d6-9ae4-bbdff851df17
• Commercial Distribution Discontinuation: 2024-09-30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISOLATOR™ 10 mL Microbial Tubes
• Version Model Number: 50C7
• 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	10811877010965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810664

FDA Product Code

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

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: 2023-09-12
• Device Publish Date: 2016-09-05

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