FDA.reportPublic FDA data

QUANTA Flash® Centromere Calibrators

Primary DI
08426950596080
Brand
QUANTA Flash® Centromere Calibrators
Company
INOVA DIAGNOSTICS, INC.
Model
701196
Device description
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.
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123880000QUANTA FLASH CENTROMEREInova Diagnostics, Inc.2014-02-07LJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950596080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950596080084269505960808426950596080

GMDN Terms#

Term, Definition table
TermDefinition
Centromere antibody IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of anticentromere antibodies in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-545-9495support@inovadx.com

Regulatory Flags#

DUNS number
188354831
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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