QUANTA Flash® h-tTG IgA Calibrators - 1. QUANTA Flash h-tTG IgA Calibrator 1: Two (2) - INOVA DIAGNOSTICS, INC.

Duns Number:188354831

Device Description: 1. QUANTA Flash h-tTG IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL pr 1. QUANTA Flash h-tTG IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to h-tTG in stabilizers and preservatives. 2. QUANTA Flash h-tTG IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to h-tTG in stabilizers and preservatives.

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More Product Details

Catalog Number

-

Brand Name

QUANTA Flash® h-tTG IgA Calibrators

Version/Model Number

701101

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

K094060

Product Code Details

Product Code

JIX

Product Code Name

Calibrator, Multi-Analyte Mixture

Device Record Status

Public Device Record Key

dee70ac1-39d2-43b4-884d-793367317c22

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