FDA.reportPublic FDA data

QUANTA Flash® dsDNA Controls

Primary DI
08426950601920
Brand
QUANTA Flash® dsDNA Controls
Company
INOVA DIAGNOSTICS, INC.
Model
701177
Device description
1. QUANTA Flash dsDNA Low Control: Two (2) barcode labeled tubes containing 0.7 mL, ready to use reagent. Controls contain human antibodies to dsDNA in stabilizers and preservatives.2. QUANTA Flash dsDNA High Control: Two (2) barcode labeled tubes containing 0.7 mL, ready to use reagent. Controls contain human antibodies to dsDNA in stabilizers, and preservatives.
Published
2016-08-31
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152013000QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsInova Diagnostics, Inc.2016-04-11LSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950601920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950601920084269506019208426950601920

GMDN Terms#

Term, Definition table
TermDefinition
Double stranded DNA antibody (anti-dsDNA) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to double stranded DNA (anti-dsDNA) 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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