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QUANTA Lite® Actin IgG ELISA Bulk Pack

Primary DI
08426950594697
Brand
QUANTA Lite® Actin IgG ELISA Bulk Pack
Company
INOVA DIAGNOSTICS, INC.
Model
708785.10
Device description
1. 10x Actin IgG ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted Actin IgG ELISA Low Positive4. 5x 1.2mL prediluted Actin IgG ELISA High Positive5. 9x 50mL HRP Sample Diluent6. 10x 25mL HRP Wash Concentrate, 40x concentrate7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 10x 10mL TMB Chromogen9. 10 x10mL HRP Stop Solution, 0.344M Sulfuric Acid
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
NJFAntibodies, Anti-Actin, Anti-Smooth Muscle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJFAntibodies, Anti-Actin, Anti-Smooth MuscleImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021648000QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISAInova Diagnostics, Inc.2002-09-20NJF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950594697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950594697084269505946978426950594697

GMDN Terms#

Term, Definition table
TermDefinition
F-Actin antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to F-actin in a clinical specimen, using an enzyme immunoassay (EIA) method.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08430793040839Aptiva® APS IgA Calibrators7251212026-06-10
08430793040518Aptiva® Celiac Disease IgG Calibrators7241012022-05-27
08430793040525Aptiva® Celiac Disease IgG Controls7241022022-05-27
08430793040570Aptiva® Celiac Disease IgA Calibrators7241212022-05-27
08430793040587Aptiva® Celiac Disease IgA Controls7241222022-05-27
08430793040778Aptiva® APS IgG Controls7251022024-03-11
08430793040907Aptiva® APS IgM Calibrators7251412024-03-11
08430793040914Aptiva® APS IgM Controls7251422024-03-11
08430793040181Aptiva® CTD Essential Calibrators7231012023-12-14
08430793040198Aptiva® CTD Essential Controls7231022023-12-14
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive Control7040732026-06-09
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive Control7040052026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive Control7040092026-06-09
08430793040761Aptiva® APS IgG Calibrators7251012024-03-11
08426950514190QUANTA Lite® C1q CIC ELISA7046202026-04-20
08430793041140Aptiva® Optical Cleaning SolutionAC10032024-03-11
08426950454373QUANTA Lite® ANA ELISA7087502016-08-31
08426950456193NOVA Lite® HEp-2 ANA Kit7081002016-08-31
08426950593461NOVA Lite® HEp-2 ANA Kit7081012016-08-31
08426950593577NOVA Lite® ANA Kit with DAPI7081022016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08426950485094QUANTA Lite® Actin IgG ELISAINOVA DIAGNOSTICS, INC.NJF2016-08-31