FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380020206
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
B1077-18
Catalog number
B1077-18
Device description
SP Rubella Test 500 Determiantion
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
20885380020206PrimaryGS10
10885380020209Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538002020620885380020206
1088538002020910885380020209

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
500
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

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
20885380020190CARDINAL 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