FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380114370
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
B1077-12
Catalog number
B1077-12
Device description
SP Brand RPR Card Test
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
GMPANTISERA, CONTROL FOR NONTREPONEMAL TESTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GMPAntisera, Control For Nontreponemal TestsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851504000VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010Ncs Diagnostics, Inc.1985-08-19GMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380114370PrimaryGS10
10885380114373Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538011437020885380114370
1088538011437310885380114373

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum reagin antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen.

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816057021796ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2023-12-19
00816057021802ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2023-12-19
B224V611VDRL CONTROL SERUM KITCENOGENICS CORPORATIONGMP2021-05-27
00613647001585Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
00613647001592Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
00613647001608Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
00613647001615Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
00613647001622Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
00613647000977Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-08
00613647001578Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-08
10613647000837Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000844Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000851Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000868Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000875Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000882Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000899Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000905Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
10613647000912Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
00816057021659ASI RPR Card Test for Syphilis ARLINGTON SCIENTIFIC, INC.GMP2017-03-16
10885380114403CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
10885380114410CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114400CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114417CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114387CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114394CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
00816057020690ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020706ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020713ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020720ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08