BD Macro-Vue™ RPR Card Test Liquid Controls 276909

GUDID 00382902769095

BD Macro-Vue™ RPR Card Test Liquid Controls

BECTON, DICKINSON AND COMPANY

Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device ID00382902769095
NIH Device Record Key355842b4-8a9b-4571-b426-4eaeee56727c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Macro-Vue™ RPR Card Test Liquid Controls
Version Model Number276909
Catalog Number276909
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com

Device Dimensions

Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter
Total Volume1.5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382902769095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GMPANTISERA, CONTROL FOR NONTREPONEMAL TESTS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-19

Devices Manufactured by BECTON, DICKINSON AND COMPANY

30382903673248 - BD Vacutainer® Push Button Blood Collection Set2024-07-16 Wingset PBBCS 23x.75 12 w/o Luer
30382903673262 - BD Vacutainer® Push Button Blood Collection Set2024-07-16 BD Vacutainer® Push Button Blood Collection Set
30382903673385 - BD Vacutainer® Push Button Blood Collection Set2024-07-16 WINGSET PBBCS 21X.75 7 LUER
30382903673415 - BD Vacutainer® Push Button Blood Collection Set2024-07-16 WINGSET PBBCS 25X.75 12 LUER
30382903673422 - BD Vacutainer® Push Button Blood Collection Set2024-07-16 WINGSET PBBCS 23X.75 12 LUER
30382903673446 - BD Vacutainer® Push Button Blood Collection Set2024-07-16 WINGSET PBBCS 21X.75 12 LUER
30382903673521 - BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder2024-07-16 WINGSET PBBCS 21X.75 12 PREATTACHED
30382903673354 - BD Vacutainer® Push Button Blood Collection Set2024-07-15 BD Vacutainer® Push Button Blood Collection Set

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.