FDA.reportPublic FDA data

QUANTA Lite® Intrinsic Factor ELISA

Primary DI
08426950454526
Brand
QUANTA Lite® Intrinsic Factor ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
708780
Device description
1.1x Intrinsic Factor ELISA microwell plate, (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x1.2mL prediluted Intrinsic Factor ELISA Low Positive4.1x 1.2mL prediluted Intrinsic Factor ELISA High Positive5.1x 50mL HRP Sample Diluent6.1x 25mL HRP Wash Concentrate, 40x concentrate7.1x 10mL HRP IgG Conjugate, (goat) 8.1x 10mL TMB Chromogen9.1x 10mL 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
LIGRadioassay, Intrinsic Factor Blocking Antibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIGRadioassay, Intrinsic Factor Blocking AntibodyClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061841000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061841000QUANTA LITE INTRINSIC FACTOR ELISAInova Diagnostics, Inc.2006-12-22LIG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950454526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950454526084269504545268426950454526

GMDN Terms#

Term, Definition table
TermDefinition
Intrinsic factor/parietal cell 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 intrinsic factor and/or parietal cells in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of conditions associated with deficiencies in intrinsic factor and/or parietal cell function/production such as autoimmune gastric disorders (e.g., pernicious anaemia, chronic atrophic gastritis), funicular myelosis, and various autoimmune endocrinopathies.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
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
08426950594208NOVA Lite® HEp-2 External EB Kits7042352016-08-31
08426950594857NOVA Lite® Auto AB Panel 7081802016-08-31
08426950595267NOVA Lite® HEp-2 External EB Kits7042302016-08-31
08430793040181Aptiva® CTD Essential Calibrators7231012023-12-14
08430793040198Aptiva® CTD Essential Controls7231022023-12-14
08426950506324NOVA Lite® ANA KSL Kit7083902016-08-31
08426950514008NOVA Lite® ANA KSL Kit7083802016-08-31
08426950514176NOVA Lite®Rat Liver , Kidney, Stomach Kit7041702016-08-31
08426950545798NOVA Lite®Rat Liver , Kidney, Stomach Kit7041802016-08-31
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
08426950627692QUANTA Flash PR3 Reagents7011352024-12-13
08430793040716Aptiva® APS IgG Reagent7251002024-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414962313IMMULITE® 2000 Systems VB Vitamin B12SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLIG2016-09-24
00630414962320IMMULITE® 2000 Systems VB Vitamin B12SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLIG2016-09-24
15099590229146Access Intrinsic Factor AbBeckman Coulter, Inc.LIG2016-09-09