FDA.reportPublic FDA data

NOVA Lite®Rat Liver , Kidney, Stomach Kit

Primary DI
08426950545798
Brand
NOVA Lite®Rat Liver , Kidney, Stomach Kit
Company
INOVA DIAGNOSTICS, INC.
Model
704180
Device description
1. 25 x Rat liver, kidney, stomach slide (10-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 15mL FITC IgG (H&L) Conjugate7. 1 x 3mL 1% Evans Blue Counterstain8. 2 x 25 PBS II Buffer (x40 conc)9. 1 x 10mL Mounting Medium10. 50 x Blotters11. 25 x Coverslips 12. 1 x instruction leaflet
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955431000RIT LIVER, KIDNEY, STOMACH IFA KITThe Binding Site, Ltd.1996-04-23DBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950545798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950545798084269505457988426950545798

GMDN Terms#

Term, Definition table
TermDefinition
Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to intrinsic factor and/or parietal cells in a clinical specimen, using a fluorescent immunoassay method. It is typically used to aid in the diagnosis of conditions associated with deficiencies in intrinsic factor and/or parietal cell function/production such as autoimmune gastric disorders (e.g., pernicious anaemia, chronic atrophic gastritis), funicular myelosis, and various autoimmune endocrinopathies.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-545-9495support@inovadx.com

Regulatory Flags#

DUNS number
188354831
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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08426950454373QUANTA Lite® ANA ELISA7087502016-08-31
08426950456193NOVA Lite® HEp-2 ANA Kit7081002016-08-31
08426950593461NOVA Lite® HEp-2 ANA Kit7081012016-08-31
08426950593577NOVA Lite® ANA Kit with DAPI7081022016-08-31
08426950594208NOVA Lite® HEp-2 External EB Kits7042352016-08-31
08426950594857NOVA Lite® Auto AB Panel 7081802016-08-31
08426950595267NOVA Lite® HEp-2 External EB Kits7042302016-08-31
08430793040181Aptiva® CTD Essential Calibrators7231012023-12-14
08430793040198Aptiva® CTD Essential Controls7231022023-12-14
08426950506324NOVA Lite® ANA KSL Kit7083902016-08-31
08426950514008NOVA Lite® ANA KSL Kit7083802016-08-31
08426950514176NOVA Lite®Rat Liver , Kidney, Stomach Kit7041702016-08-31
08426950593539NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081502016-08-31
08426950596387NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081552016-08-31
08426950621843NOVA Lite® DAPI ANA Kit7043202016-08-31
08426950627692QUANTA Flash PR3 Reagents7011352024-12-13
08430793040716Aptiva® APS IgG Reagent7251002024-03-11
08430793040853Aptiva® APS IgM Reagent7251402024-03-11

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