Proteinase-3 IgG ELISA EIA-2778

GUDID 04048474027785

The DRG ELISA Proteinase-3 (PR-3) Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody to proteninase-3 in human serum. The test is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of anti-neutrophil cytoplasmic antibodies (ANCA).

DRG Instruments Gesellschaft mit beschränkter Haftung

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex

• Primary Device ID: 04048474027785
• NIH Device Record Key: ed22fdd3-0324-41ad-8be5-7d98a5896ccf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proteinase-3 IgG ELISA
• Version Model Number: EIA-2778
• Catalog Number: EIA-2778
• Company DUNS: 317134468
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• 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: true
• 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: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.com
• Phone: 973-564-7555
• Email: corp@drg-international.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048474027785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964448

FDA Product Code

• MOB: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-06
• Device Publish Date: 2023-08-29

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