FDA.report

BD Macro-Vue™ RPR Card Test Control Cards, 18mm

Primary DI
30382902767092
Brand
BD Macro-Vue™ RPR Card Test Control Cards, 18mm
Company
BECTON, DICKINSON AND COMPANY
Model
276709
Catalog number
276709
Device description
BD Macro-Vue™ RPR Card Test Control Cards, 18mm
Published
2016-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GMPANTISERA, CONTROL FOR NONTREPONEMAL TESTS

Product Code Classifications

CodeDeviceSpecialtyClass
GMPAntisera, Control For Nontreponemal TestsMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30382902767092PrimaryGS10
00382902767091Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290276709230382902767092
00382902767091003829027670913829027670910382902767091

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags

DUNS number
122561087
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

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00816057021796ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2023-12-19
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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
00816057021659ASI RPR Card Test for Syphilis ARLINGTON SCIENTIFIC, INC.GMP2017-03-16
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
00816057020737RPR Card Test for Syphilis ARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020744ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020768ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020775ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020782ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020799ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020805ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020812ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020829ASI RPR Card for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08
00816057020836ASI RPR Card Test for SyphilisARLINGTON SCIENTIFIC, INC.GMP2016-07-08