FDA.reportPublic FDA data

Rubajet 500 TESTS

Primary DI
08426950590583
Brand
Rubajet 500 TESTS
Company
BIOKIT, S.A.
Model
300024012
Device description
5 x 1.7 ml LATEX REAGENT2 x 1.5 ml HIGH POSITIVE CONTROL2 x 1.5 ml LOW POSITIVE CONTROL2 x 15 ml DILUENT BUFFER45 disposable slides
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
LQNLatex Agglutination Assay, Rubella

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LQNLatex Agglutination Assay, RubellaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954920000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954920000MUREX RUB-EXMurex Diagnostics, Inc.1996-08-21LQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950590583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950590583084269505905838426950590583

GMDN Terms#

Term, Definition table
TermDefinition
Rubella virus total antibody IVD, kit, rapid agglutination, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to Rubella virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid agglutination method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

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
1-800-926-3353support@inovadx.com

Regulatory Flags#

DUNS number
460055742
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
08426950639725BIO-FLASH3710-03442016-09-23
08426950344773Color Mono 50 TESTS3000-10052016-09-23
08426950590453ASO Titer Control3000210602016-09-23
08426950590477RF Titer Control3000210622016-09-23
08426950590569Rubagen 100 TESTS3000240012016-09-23
08426950590576Rubajet 100 TESTS3000240112016-09-23
08426950589365Rheumajet CRP 100 TESTS3000-70512016-09-23
08426950590460CRP Titer Control3000210612016-09-23
08426951056439biokitHSV-23000280012022-10-10
08426950001676Monogen 50 TESTS3000-10012016-09-23
08426950585350Monogen 150 TESTS3000-10022016-09-23
08426950589334Rheumajet RF 100 TESTS3000-70332016-09-23
08426950590613Rheumajet RF 50 TESTS3000270342016-09-23
08426950592327Biokit RPR 500 TESTS3006255502016-09-23
08426950457305Rheumajet ASO 100 TESTS3000-70102016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00006136471219Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2017-10-27
00006136471226Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2017-10-27
00006136471233Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2017-10-27
00006136471240Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2017-10-27
00613647001219Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2016-09-24
00613647001226Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2016-09-24
00613647001233Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2016-09-24
00613647001240Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.LQN2016-09-24
08426950590569Rubagen 100 TESTSBIOKIT, S.A.LQN2016-09-23
08426950590576Rubajet 100 TESTSBIOKIT, S.A.LQN2016-09-23
20885380020183CARDINAL HEALTHCardinal Health 200, LLCLQN2016-09-15
20885380020190CARDINAL HEALTHCardinal Health 200, LLCLQN2016-09-15
20885380020206CARDINAL HEALTHCardinal Health 200, LLCLQN2016-09-15
00816057020423ASI Rubella TestARLINGTON SCIENTIFIC, INC.LQN2016-07-08
00816057020430ASI Rubella TestARLINGTON SCIENTIFIC, INC.LQN2016-07-08
00816057020447ASI Rubella TestARLINGTON SCIENTIFIC, INC.LQN2016-07-08
00816057020454ASI Rubella TestARLINGTON SCIENTIFIC, INC.LQN2016-07-08
00816057021635ASI Rubella Test Control SetARLINGTON SCIENTIFIC, INC.LQN2016-07-08