QUANTA Lite® CCP3 IgG ELISA Bulk Pack - 1. 10x CCP3 IgG ELISA microwell plates (12-1 x 8 - INOVA DIAGNOSTICS, INC.

Duns Number:188354831

Device Description: 1. 10x CCP3 IgG ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted 1. 10x CCP3 IgG ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted CCP3 IgG ELISA Low Positive4. 5x 1.2mL prediluted CCP3 IgG ELISA High Positive/Calibrator A5. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator B6. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator C7. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator D8. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP CCP3 IgG Conjugate, (goat), anti-human IgG12. 10 x10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid

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More Product Details

Catalog Number

-

Brand Name

QUANTA Lite® CCP3 IgG ELISA Bulk Pack

Version/Model Number

704535.10

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

-

Product Code Details

Product Code

NHX

Product Code Name

Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Device Record Status

Public Device Record Key

251c9c06-2e60-4234-80c3-a94fdfc2bb32

Public Version Date

March 29, 2018

Public Version Number

2

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