PR3 IgG Test System PR3396

GUDID 00813545029043

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

Primary Device ID	00813545029043
NIH Device Record Key	fd934edd-1ee0-4152-a74c-895f816ca73d
Commercial Distribution Status	In Commercial Distribution
Brand Name	PR3 IgG Test System
Version Model Number	PR3396
Catalog Number	PR3396
Company DUNS	155424708
Company Name	SCIMEDX CORPORATION
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	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00813545029043 [Primary]

MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

Steralize Prior To Use	false
Device Is Sterile	false

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