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 Staphylococcus aureus culture isolate antigen IVD, kit, agglutination 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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