DR900A

GUDID 00816576021840

MRSA-Screen consists of latex reagent sensitized with a monoclonal antibody against penici|lin—binding protein 2'(2a). or PBP2' (PBP2a), together with control latex and 2'extraction reagents to rapidly extract PBP2' from the bacterial cell membranes of MRSA. Extracts are prepared by boiling a suspension of S. aureus cells under alkaline conditions, followed by neutralization and a centrifugation step. The supernatant is subsequently mixed with the latex reagents on a test card and visible clumping or agglutination within three minutes with the sensitized latex but not the control latex confirms the presence of MRSA. MATERIALS SUPPLIED Sensitized Test Latex - (dropper bottle with pink cap) Latex particles are sensitized with a monoclonal antibody against PBP2'. Control Latex - (dropper bottle with a blue cap) Latex particles are sensitized with a monoclonal antibody of the same IgG subclass but against a human protein showing no reactivity with proteins of Staphylococcus aureus . Extraction Reagent 1 - (green cap) 0.1 mol/L NaOH Extraction Reagent 2 - (yellow cap) 0.5 mol/L KH 2 PO 4 Test Cards Mixing Sticks Package Insert

HARDY DIAGNOSTICS

Staphylococcus aureus culture isolate antigen IVD, kit, agglutination

• Primary Device ID: 00816576021840
• NIH Device Record Key: 21108fe4-3b22-4971-96b9-d94682ab42e2
• Commercial Distribution Discontinuation: 2018-09-27
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: DR900A
• Catalog Number: DR900A
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576021840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011400

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-31
• Device Publish Date: 2016-09-23

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