FDA.reportPublic FDA data

QUANTA Lite® Ribosome P ELISA

Primary DI
08426950506348
Brand
QUANTA Lite® Ribosome P ELISA
Company
INOVA DIAGNOSTICS, INC.
Model
708600
Device description
1. 1x Ribosome P ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Ribosome P ELISA Low Positive4. 1x 1.2mL prediluted Ribosome P ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 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
MQAAnti-Ribosomal P Antibodies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQAAnti-Ribosomal P AntibodiesImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981237000QUANTA LITE RIBOSOME P ELISAInova Diagnostics, Inc.1998-06-05MQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950506348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950506348084269505063488426950506348

GMDN Terms#

Term, Definition table
TermDefinition
Ribosomal phosphoprotein 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 ribosomal phosphoprotein 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
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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
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08430793040716Aptiva® APS IgG Reagent7251002024-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07333066015538EliA Rib-P WellPhadia ABMQA2021-10-08
07333066014869EliA Rib-P WellPhadia ABMQA2021-10-08
04049016027225Anti-ribosomal P Proteins ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMQA2016-09-24
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04049016124900EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGMQA2016-09-24
04049016124917EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGMQA2016-09-24
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00847865000093BioPlex 2200BIO-RAD LABORATORIES, INC.MQA2016-09-12
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00847865002448BioPlex 2200BIO-RAD LABORATORIES, INC.MQA2016-09-12
00847865002721BioPlex 2200BIO-RAD LABORATORIES, INC.MQA2016-09-12
00847865012331BioPlex 2200BIO-RAD LABORATORIES, INC.MQA2016-09-12