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

Devices Manufactured by Alere Scarborough, Inc.

• 10811877010545 - Alere NMP22 Test: 2023-09-14 For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA).
• 10811877010606 - Alere NMP22 BladderChek Control Kit: 2023-09-14 The Alere NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control fo
• 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