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
50192253071595CONVERTORS8184NA8184NA2026-06-02
50192253071601CONVERTORS8187N8187N2026-06-02
50192253071618CONVERTORS8188NC8188NC2026-06-02
50192253071625CONVERTORS8189N8189N2026-06-02
20192253005971CONVERTORSAT7004AT70042019-04-16
20192253017080Kendall31.3876.0431.3876.042023-03-16
50885380183001CARDINAL HEALTH50001218500012182023-08-11
50885380182998CARDINAL HEALTH50001217500012172023-08-11
10197106817643CARDINAL HEALTHSEYHBDPANBSEYHBDPANB2026-06-01
10198956004887CARDINAL HEALTHSBAHFRPASCSBAHFRPASC2026-06-01
10198956201804CARDINAL HEALTH32-0828C32-0828C2026-06-01
10198956209220CARDINAL HEALTHPG33GLVWBPG33GLVWB2026-06-01
10198956225992CARDINAL HEALTHSOP54PPUOBSOP54PPUOB2026-06-01
10198956245754CARDINAL HEALTHSBACGKTACFSBACGKTACF2026-06-01
10198956248908CARDINAL HEALTHSAN43CATOBSAN43CATOB2026-06-01
10198956269323CARDINAL HEALTHSOP4QSHCLBSOP4QSHCLB2026-06-01
10198956311282CARDINAL HEALTHSCV11VSJKJSCV11VSJKJ2026-06-01
10198956312043CARDINAL HEALTHPW30PSPRHPW30PSPRH2026-06-01
10198956314634CARDINAL HEALTHSBAMIFPACBSBAMIFPACB2026-06-01
10198956314894CARDINAL HEALTHSEN42HNAMDSEN42HNAMD2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B224V611VDRL CONTROL SERUM KITCENOGENICS CORPORATIONGMP2021-05-27
00613647001585Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
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00613647001615Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-18
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00613647000977Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2019-04-08
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10613647000837Sure-VueFISHER SCIENTIFIC COMPANY L.L.C.GMP2017-06-27
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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