FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380020183
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
B1077-16
Catalog number
B1077-16
Device description
SP Rubella Test 30 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
20885380020183PrimaryGS10
10885380020186Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538002018320885380020183
1088538002018610885380020186

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
30
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

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
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