c-ANCA (PR3) ELISA EIA-3596

GUDID 04048474035964

c-ANCA (PR 3) ELISA is a test system for the quantitative measurement of IgG class autoantibodies against proteinase 3 (PR3) in human serum or plasma.

DRG Instruments Gesellschaft mit beschränkter Haftung

Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04048474035964
• NIH Device Record Key: cde5df97-c30f-4bc0-b478-49219854a84a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: c-ANCA (PR3) ELISA
• Version Model Number: EIA-3596
• Catalog Number: EIA-3596
• 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: 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: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(973)564-7555
• Email: corp@drg-international.com
• Phone: +1(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
• 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	04048474035964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974702

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-30
• Device Publish Date: 2019-06-05

On-Brand Devices [c-ANCA (PR3) ELISA]

• 00404847435962: c-ANCA (PR 3) ELISA is a test system for the quantitative measurement of IgG class autoantibodie
• 04048474035964: c-ANCA (PR 3) ELISA is a test system for the quantitative measurement of IgG class autoantibodie