QUANTA Lite® Histone ELISA - 1. 1x Histone ELISA microwell plate (12-1 x 8 - INOVA DIAGNOSTICS, INC.

Duns Number:188354831

Device Description: 1. 1x Histone ELISA microwell plate (12-1 x 8 wells), with holder2. 1 x1.2mL prediluted E 1. 1x Histone ELISA microwell plate (12-1 x 8 wells), with holder2. 1 x1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Histone ELISA Low Positive4. 1x 1.2mL prediluted Histone ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 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® Histone ELISA

Version/Model Number

708520

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

K934053

Product Code Details

Product Code

LLL

Product Code Name

Extractable Antinuclear Antibody, Antigen And Control

Device Record Status

Public Device Record Key

f7ea67e3-cbfa-48e1-aa4e-23dfb5e75894

Public Version Date

July 06, 2018

Public Version Number

3

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