DxSelect™ Sample Diluent EL1608

GUDID 10816101022226

DIASORIN MOLECULAR LLC

Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD Immunohistochemistry antibody diluent IVD

• Primary Device ID: 10816101022226
• NIH Device Record Key: 698e7207-3400-4e38-afe0-77ec66718ae9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxSelect™ Sample Diluent
• Version Model Number: EL1608
• Catalog Number: EL1608
• Company DUNS: 080271715
• Company Name: DIASORIN MOLECULAR LLC
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 562-240-6500
• Email: TS.Molecular@DiaSorin.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
• 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
• 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	10816101022226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993754

FDA Product Code

• MXJ: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

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: 2024-07-04
• Device Publish Date: 2016-09-22

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• 10816101022301 - DxSelect™ - Stop Reagent: 2024-07-05
• 10816101022318 - West Nile Virus IgG DxSelect™ - IgG Conjugate: 2024-07-05
• 10816101021014 - HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen Strips: 2024-07-04
• 10816101021021 - HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive Control: 2024-07-04
• 10816101021038 - HSV-1 and HSV-2 Immunoblot IgG Negative Control: 2024-07-04
• 10816101022042 - West Nile Virus DxSelect™ Negative Control: 2024-07-04