FDA.reportPublic FDA data

QUANTA Flash® GBM Controls

Primary DI
08426950594888
Brand
QUANTA Flash® GBM Controls
Company
INOVA DIAGNOSTICS, INC.
Model
701142
Device description
1. QUANTA Flash GBM Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash GBM Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to GBM, prediluted, ready to use, 0.5mL (containing buffer, protein 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
K112545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112545000QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBMInova Diagnostics, Inc.2012-07-31MOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950594888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950594888084269505948888426950594888

GMDN Terms#

Term, Definition table
TermDefinition
Glomerular basement membrane antibody (Goodpasture antibody) 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 glomerular basement membrane (anti-GBM) or Goodpasture 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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08426950514176NOVA Lite®Rat Liver , Kidney, Stomach Kit7041702016-08-31
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08426950593539NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081502016-08-31
08426950596387NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081552016-08-31
08426950621843NOVA Lite® DAPI ANA Kit7043202016-08-31
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