QUANTA Flash RF IgA Controls - 1. QUANTA Flash RF IgA Negative Control: Two (2) - INOVA DIAGNOSTICS, INC.

Duns Number:188354831

Device Description: 1. QUANTA Flash RF IgA Negative Control: Two (2) barcode labeled tubes containing 0.5mL, r 1. QUANTA Flash RF IgA Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgA in stabilizers and preservatives.2. QUANTA Flash RF IgA Postitive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgA in stabilizers and preservatives.

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More Product Details

Catalog Number

-

Brand Name

QUANTA Flash RF IgA Controls

Version/Model Number

701347

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)

-

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

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

f56d346f-2c9e-416b-a11a-16586cde39a5

Public Version Date

September 30, 2019

Public Version Number

1

DI Record Publish Date

September 20, 2019

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