QUANTA Lite® CCP3.1 IgG/IgA ELISA - 1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 - INOVA DIAGNOSTICS, INC.

Duns Number:188354831

Device Description: 1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predil 1. 1x CCP3.1 IgG/IgA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Low Positive4. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA High Positive/Calibrator A5. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator B6. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator C7. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator D8. 1x 1.2mL prediluted CCP3.1 IgG/IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 100mL High Specificity Wash Concentrate, 10x concentrate11. 1x 10mL HRP CCP3.1 IgG/IgA Conjugate, (goat), anti-human IgG/IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

QUANTA Lite® CCP3.1 IgG/IgA ELISA

Version/Model Number

704550

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

K072944

Product Code Details

Product Code

NHX

Product Code Name

Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Device Record Status

Public Device Record Key

96ff858a-9aa9-427f-8b22-a6e3f02af02a

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