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

Duns Number:188354831

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

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More Product Details

Catalog Number

-

Brand Name

QUANTA Flash® Centromere Calibrators

Version/Model Number

701196

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

K123880

Product Code Details

Product Code

JIX

Product Code Name

Calibrator, Multi-Analyte Mixture

Device Record Status

Public Device Record Key

6d32f034-a626-42cc-ab4c-b555e5273965

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 30, 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