NOVA Gel® SS-A/SS-B “T” Extractable Nuclear AutoantibodyReagents

GUDID 08426950594048

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, precipitation/immunodiffusion

Primary Device ID	08426950594048
NIH Device Record Key	a73954d4-550b-4718-b533-82f586d22c5e
Commercial Distribution Discontinuation	2018-05-02
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	NOVA Gel® SS-A/SS-B “T” Extractable Nuclear AutoantibodyReagents
Version Model Number	708455
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

Device Issuing Agency	Device ID
GS1	08426950594048 [Primary]

LLL	Extractable Antinuclear Antibody, Antigen And Control

Steralize Prior To Use	false
Device Is Sterile	false

08426950454373 - QUANTA Lite® ANA ELISA	2026-02-09 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL predilu
08426950456193 - NOVA Lite® HEp-2 ANA Kit	2026-02-09 1. 20x Hep- 2 ANA Slide (12 well) 2. 1x 0.5mL IFA System Negative Control 3. 1x 15mL FITC IgG Conjugate
08426950593461 - NOVA Lite® HEp-2 ANA Kit	2026-02-09 1. 5 x 12-well HEp-2 Substrate Slides 2. 1 x 4mL FITC Anti-Human IgG Conjugate 3. 1 x 0.5 mL ANA Titratable Endpoint Pattern Con
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
08426950595267 - NOVA Lite® HEp-2 External EB Kits	2026-02-09 1. 10x 6-well HEp 2 ANA Substrate Slides 2. 1x 1mL Homo. Ptn. (use w/Conj. 504070 or 504088) 3. 1x mL Centromere Positive Contr
08426950627692 - QUANTA Flash PR3 Reagents	2024-12-23 1. QUANTA Flash PR3 Reagent Cartridge

Mark Image Registration \| Serial	Company Trademark Application Date
NOVA GEL 87596838 not registered Dead/Abandoned	Nguyen, John 2017-09-05
NOVA GEL 77968875 3879165 Dead/Cancelled	Inova Diagnostics, Inc. 2010-03-25