QUANTA Flash PR3 Reagents

GUDID 08426950627692

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

Primary Device ID	08426950627692
NIH Device Record Key	ae1091e1-cdac-4866-877d-088d28e5ef5f
Commercial Distribution Status	In Commercial Distribution
Brand Name	QUANTA Flash PR3 Reagents
Version Model Number	701135
Company DUNS	188354831
Company Name	INOVA DIAGNOSTICS, 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

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

Device Issuing Agency	Device ID
GS1	08426950627692 [Primary]

MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

Steralize Prior To Use	false
Device Is Sterile	false

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08426950593577 - NOVA Lite® ANA Kit with DAPI	2026-02-09 1. 20x ANA Hep- 2 -QR Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate with DAPI
08426950594208 - NOVA Lite® HEp-2 External EB Kits	2026-02-09 1. 20x 12-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x 1 mL Centromere Positive Con
08426950594857 - NOVA Lite® Auto AB Panel	2026-02-09 1. 1x 0.5mL ANA Homogeneous/dsDNA pattern 2. 1x 0.5 ANA Speckled Pattern 3. 1x 0.5 ANA Nucleolar Pattern 4. 1x 0.5 ANA Centr
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08426950627692 - QUANTA Flash PR3 Reagents	2024-12-231. QUANTA Flash PR3 Reagent Cartridge
08426950627692 - QUANTA Flash PR3 Reagents	2024-12-23 1. QUANTA Flash PR3 Reagent Cartridge