EL-ANCA: anti-PR3 104-115

GUDID 00854473003231

ANTI-PROTEINASE-3 (PR3) ANTIBODIES (C-ANCA) ELISA TEST KIT, 96 TESTS

THERA-TEST LABORATORIES, INC

Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00854473003231
• NIH Device Record Key: b0394eb2-0e58-4202-8288-e0414598699f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EL-ANCA: anti-PR3
• Version Model Number: 104-115
• Catalog Number: 104-115
• Company DUNS: 194336954
• Company Name: THERA-TEST LABORATORIES, INC
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854473003231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061376

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: 2018-03-29
• Device Publish Date: 2016-08-15

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