ELISA ANCA Screen Smart Kit Test System SM2Z9681G

GUDID 00845533000161

The ZEUS ELISA ANCA Screen Test System is intended for the qualitative detection of anti-Myeloperoxidase and/or anti-Proteinase-3 IgG antibody 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). MPO and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulamatosis, ICGN, MPA and PRS. This test is for In Vitro diagnostic use.

ZEUS SCIENTIFIC, INC.

Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533000161
• NIH Device Record Key: f69ed228-35ca-4a81-9425-b77c2f172d74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELISA ANCA Screen Smart Kit Test System
• Version Model Number: SM2Z9681G
• Catalog Number: SM2Z9681G
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533000161 [Primary]

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: 2016-09-24

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