Legionella IFA Polyvalent Conjugate

GUDID 10816101020017

DIASORIN MOLECULAR LLC

Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent

• Primary Device ID: 10816101020017
• NIH Device Record Key: 32e113d1-dd0f-4e6d-98ae-0d35d128573b
• Commercial Distribution Discontinuation: 2017-02-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Legionella IFA Polyvalent Conjugate
• Version Model Number: IF0010
• Company DUNS: 080271715
• Company Name: DIASORIN MOLECULAR LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816101020017 [Primary]

FDA Product Code

• LHL: Reagents, Antibody, Legionella, Direct & Indirect Fluorescent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-08-09
• Device Publish Date: 2016-09-22

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