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)

• 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

Devices Manufactured by AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

• B24211GLUHUE010 - Glucagon ELISA: 2024-10-31 The Glucagon ELISA is a quantitative Enzyme-Linked Immunosorbent Assay for the determination of Glucagon in human EDTA plasma sa
• B24280PANHUFC1000 - ALPCO Pancreatic Elastase CLIA: 2024-08-02 The Pancreatic Elastase CLIA kit is a chemiluminescent immunoassay (CLIA) intended for use by trained laboratory personnel for t
• B24220TT3HUE011 - Total Triiodothyronine (Total T3) ELISA: 2024-07-30 The Total Triiodothyronine (Total T3) ELISA Kit is intended for the quantitative determination of total triiodothyronine (T3) co
• B24280CALPHUIT2000 - ALPCO Calprotectin Immunoturbidimetric Assay: 2023-08-28 The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of hu
• B24280CALPHUITCAL0 - Calprotectin Immunoturbidimetric Assay - Calibrators: 2023-08-28 The Calprotectin Immunoturbidimetric Assay - Calibrators is an accessory used in conjunction with the Calprotectin Immunoturbidi
• B24280CALPHUITCON0 - ALPCO Calprotectin Immunoturbidimetric Assay: 2023-08-28 The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with the Calprotectin Immunoturbidimet
• B24280CALPHUIT100 - ALPCO Calprotectin Immunoturbidimetric Assay: 2023-06-19 The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of hu
• B24220EDLHUUE010 - Ultrasensitive Estradiol ELISA: 2023-06-15 The Ultrasensitive Estradiol ELISA is an enzyme immunoassay for the quantitative measurement of estradiol in serum or plasma (ED