ISOSTAT® Press and Rack

GUDID 00811877010050

ISOSTAT® Press and Rack for the processing of ISOLATOR Microbial Tubes for adults.

Alere Scarborough, Inc.

Instrument/analyser test tube rack IVD

• Primary Device ID: 00811877010050
• NIH Device Record Key: 2e44a94a-6f48-444a-b3ae-1b719b28b315
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISOSTAT® Press and Rack
• Version Model Number: 50C2
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	00811877010050 [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-05

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