NOVA Lite®Rat Liver , Kidney, Stomach Kit

GUDID 08426950514176

1. 10 x Rat liver, kidney, stomach slide (5-well) 2. 1 x 1mL ANA Homogeneous Pattern (prediluted) 3. 1 x 1mL IFA System Negative Control (prediluted) 4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 7mL FITC IgG (H&L) Conjugate 7. 1 x 3mL 1% Evans Blue Counterstain 8. 2 x 25mL PBS II Buffer (x40 conc) 9. 1 x 3mL Mounting Medium 10. 20 x Blotters 11. 10 x Coverslips 12. 1 x instruction leaflet

INOVA DIAGNOSTICS, INC.

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Primary Device ID08426950514176
NIH Device Record Key83c5e2b9-5480-4417-8cdd-c3f0207efe44
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVA Lite®Rat Liver , Kidney, Stomach Kit
Version Model Number704170
Company DUNS188354831
Company NameINOVA DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com
Phone1-800-545-9495
Emailsupport@inovadx.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108426950514176 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-06-08
Device Publish Date2016-08-31

On-Brand Devices [NOVA Lite®Rat Liver , Kidney, Stomach Kit]

084269505457981. 25 x Rat liver, kidney, stomach slide (10-well) 2. 1 x 1mL ANA Homogeneous Pattern (predilute
084269505141761. 10 x Rat liver, kidney, stomach slide (5-well) 2. 1 x 1mL ANA Homogeneous Pattern (prediluted

Trademark Results [NOVA Lite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVA LITE
NOVA LITE
77968845 3879164 Live/Registered
Inova Diagnostics, Inc.
2010-03-25
NOVA LITE
NOVA LITE
76038820 not registered Dead/Abandoned
NAVAJO MANUFACTURING CO.
2000-05-02

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