Anti-ds-DNA-G ELISA 35-DSGHU-E01

GUDID B24235DSGHUE010

Anti-ds-DNA-G ELISA is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detect

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B24235DSGHUE010
• NIH Device Record Key: 9d2a05d0-955f-4936-8279-7e29e5cf79f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-ds-DNA-G ELISA
• Version Model Number: 35-DSGHU-E01
• Catalog Number: 35-DSGHU-E01
• Company DUNS: 784143778
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• 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: 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: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B24235DSGHUE010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041628

FDA Product Code

• LSW: Anti-Dna Antibody, Antigen And Control

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: 2018-07-06
• Device Publish Date: 2017-01-18

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