FDA.reportPublic FDA data

BD Macro-Vue™ RPR™ Card Test Control Card

Primary DI
30382902767092
Brand
BD Macro-Vue™ RPR™ Card Test Control Card
Company
BECTON, DICKINSON AND COMPANY
Model
276709
Catalog number
276709
Device description
BD Macro-Vue™ RPR™ Card Test Control Card
Published
2016-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GMPANTISERA, CONTROL FOR NONTREPONEMAL TESTS

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902767092PrimaryGS10
00382902767091Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290276709230382902767092
00382902767091003829027670913829027670910382902767091

GMDN Terms#

Term, Definition table
TermDefinition
Treponema pallidum reagin antibody IVD, kit, agglutinationA collection of reagents and other associated materials 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 using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382903935314Nexiva3935313935312026-07-30
00382903935321Nexiva3935323935322026-07-30
00382903935338Nexiva3935333935332026-07-30
00382903935345Nexiva3935343935342026-07-30
00382903935352Nexiva3935353935352026-07-30
00382903935369Nexiva3935363935362026-07-30
00382903935376Nexiva3935373935372026-07-30
00382903935383Nexiva3935383935382026-07-30
00885403523000FOGARTY SOFTJAWCSOFT6CSOFT62026-07-30
00885403523161FOGARTY HYDRAJAWHYDRA33HYDRA332026-07-30
00885403523253FOGARTY SOFTJAWSOFT33SOFT332026-07-30
00885403523277FOGARTY SOFTJAWSOFT86SOFT862026-07-30
00885403529637Acumen IQAIQCAAIQCA2026-07-29
00885403529668Acumen IQAIQCSAIQCS2026-07-29
00885403529774ClearSight JrCSCJR1CSCJR12026-07-29
00885403529781ClearSightCSCLCSCL2026-07-29
00885403529798ClearSightCSCMCSCM2026-07-29
00885403529811ClearSightCSCSCSCS2026-07-29
00885403529828VitaWaveVWCAVWCA2026-07-29
00885403522393Swan-Ganz834F75834F752026-07-27

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
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