FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380114410
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
B1077-64
Catalog number
B1077-64
Device description
SP RPR Carbon Antigen Merc Free 3ML
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
20885380114417PackageGS13In Commercial Distribution
10885380114410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538011441720885380114417
1088538011441010885380114410

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

Regulatory Flags#

DUNS number
961027315
Device count
1
Lot or batch
true
No 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
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
20885380114400CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114417CARDINAL HEALTHCardinal Health 200, LLCGMP2016-09-15
20885380114370CARDINAL 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