FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380020190
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
B1077-17
Catalog number
B1077-17
Device description
SP Rubella Test 100 Determination
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K031490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031490000RUBELLACOLImmunostics Inc.,2003-07-16LQN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380020190PrimaryGS10
10885380020193Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538002019020885380020190
1088538002019310885380020193

GMDN Terms#

Term, Definition table
TermDefinition
Rubella virus total antibody IVD, kit, agglutination, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Rubella virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an agglutination method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
100
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

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
08426950590583Rubajet 500 TESTSBIOKIT, S.A.LQN2016-09-23
20885380020183CARDINAL 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