NOVA Lite®Rat Liver , Kidney, Stomach Kit - 1. 25 x Rat liver, kidney, stomach slide - INOVA DIAGNOSTICS, INC.

Duns Number:188354831

Device Description: 1. 25 x Rat liver, kidney, stomach slide (10-well)2. 1 x 1mL ANA Homogeneous Pattern (pred 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

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More Product Details

Catalog Number

-

Brand Name

NOVA Lite®Rat Liver , Kidney, Stomach Kit

Version/Model Number

704180

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K955431

Product Code Details

Product Code

DBL

Product Code Name

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Device Record Status

Public Device Record Key

263573c3-aff0-4a69-854e-45e88ecea5e7

Public Version Date

June 08, 2021

Public Version Number

4

DI Record Publish Date

August 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INOVA DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 215