NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit

GUDID 08426951056538

1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide 2. 1 x 15mL FITC Anti-Human IgG Conjugate with DAPI 3. 1 x 0.5mL dsDNA Positive 4. 1 x 0.5mL IFA System Negative Control 5. 2 x 25mL PBS II Concentrate (40x) 6. 1 x 7mL Mounting Medium 7. 1 x 20 Coverslips

INOVA DIAGNOSTICS, INC.

Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay Double stranded DNA antibody (anti-dsDNA) IVD, kit, fluorescent immunoassay
Primary Device ID08426951056538
NIH Device Record Key84c4e428-3b3a-4c7e-a1ea-d2337316d780
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVA Lite® DAPI dsDNA Crithidia Luciliae Kit
Version Model Number708215
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
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
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
GS108426951056538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTLAnti-Dna Indirect Immunofluorescent Solid Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

Devices Manufactured by INOVA DIAGNOSTICS, INC.

08426951056538 - NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit2021-04-081. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide 2. 1 x 15mL FITC Anti-Human IgG Conjugate with DAPI 3. 1 x 0.5mL dsDNA Positive 4. 1 x 0.5mL IFA System Negative Control 5. 2 x 25mL PBS II Concentrate (40x) 6. 1 x 7mL Mounting Medium 7. 1 x 20 Coverslips
08426951056538 - NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit2021-04-08 1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide 2. 1 x 15mL FITC Anti-Human IgG Conjugate with DAPI 3. 1 x 0.5mL dsDN
08426950914693 - QUANTA Flash Calprotectin Extraction Buffer2020-11-06 1. QUANTA Flash Calprotectin Extraction Buffer (2.5X): Two (2) labeled bottles containing 125 mL, concentrated reagent.
08426950657484 - QUANTA Lite® Calprotectin ELISA2020-08-21 1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgG):1x15mL vial. 3. Substrate: 1 x15 ml vial. 4. Washin
08426950913337 - QUANTA LITE®Calprotectin Extended Range2020-08-21 1. Antibody coated plate 12x8 wells coated with antibody against calprotectin. Plastic sealed bag containing a desiccant. 2. Enz
08426950846833 - Fecal Extraction Device2020-08-20 -100 ea. fecal extraction devices containing 2.8 mL of extraction buffer -100 ea. white caps
08426950928782 - QUANTA Flash® Calprotectin Controls2020-04-06 1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls conta
08426951289240 - QUANTA Flash® aCL IgM Reagents2019-10-07 1. 1 QUANTA Flash aCL IgM Reagent Cartridge 2. 1 QUANTA Flash aCL IgM Calibrator 1 3. 1 QUANTA Flash aCL IgM Calibrator 2
08426951289257 - QUANTA Flash® B2GP1 IgA Reagents2019-10-07 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge 2. 1 QUANTA Flash B2GP1 IgA Calibrator 1 3. 1 QUANTA Flash B2GP1 IgA Calibrator 2

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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