QUANTA Lite® SLA ELISA - (Soluble Liver Antigen)1.1x SLA ELISA microwell - INOVA DIAGNOSTICS, INC.

Duns Number:188354831

Device Description: (Soluble Liver Antigen)1.1x SLA ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1. (Soluble Liver Antigen)1.1x SLA ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted SLA ELISA Low Positive4.1x 1.2mL prediluted SLA ELISA High Positive5.1x 50mL HRP Sample Diluent 6.1x 25mL HRP Wash Concentrate, 40x concentrate7.1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8.1x 10mL TMB Chromogen9.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

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More Product Details

Catalog Number

-

Brand Name

QUANTA Lite® SLA ELISA

Version/Model Number

708775

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

K021482

Product Code Details

Product Code

NIY

Product Code Name

Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis

Device Record Status

Public Device Record Key

175079a5-ed9c-4464-b2d1-c44caa6ad740

Public Version Date

August 24, 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