Clearview PBP2a SA Culture Colony Test

GUDID 10811877011238

A rapid test for the qualitative detection of PBP2a in Staphylococcus aureus isolates.

Alere Scarborough, Inc.

Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit

• Primary Device ID: 10811877011238
• NIH Device Record Key: e189e27a-ea44-48fa-aea6-412e1e4e703e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clearview PBP2a SA Culture Colony Test
• Version Model Number: 893-000
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877011238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133851

FDA Product Code

• MYI: System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

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: 2020-01-28
• Device Publish Date: 2020-01-20

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