BD Macro-Vue™ Card Test Rotator, Model 51 278051

GUDID 00382902780519

BD Macro-Vue™ Card Test Rotator, Model 51

BECTON, DICKINSON AND COMPANY

Treponema pallidum reagin antibody IVD, kit, agglutination
Primary Device ID00382902780519
NIH Device Record Key15ce7747-e9a7-4654-a1f0-e2f5021d8a6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Macro-Vue™ Card Test Rotator, Model 51
Version Model Number278051
Catalog Number278051
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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
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

Height5.25 Inch
Height5.25 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch
Depth8 Inch
Width7 Inch
Height5.25 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382902780519 [Primary]

FDA Product Code

DHRSYSTEM, TEST, RHEUMATOID FACTOR
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-05-19

Devices Manufactured by BECTON, DICKINSON AND COMPANY

60382904422884 - BD BACTEC™ Myco/F Lytic Culture Vials2025-02-17 BD BACTEC™ Myco/F Lytic Culture Vials
00382906666574 - Horizon2025-02-14 BD Horizon™ Anti-TCRg/d -1 (11F2) BV421
00382906666444 - N/A2025-02-12 BD® CD24 (ML5) PE
00382906666451 - N/A2025-02-12 BD® Anti-Human IgD (IA6-2) PerCP-Cy5.5
00382906666468 - N/A2025-02-12 BD® CD13 (WM15) PerCP-Cy5.5
00382906666499 - N/A2025-02-12 BD® CD28 (L293) APC-H7
00382906666505 - Horizon2025-02-12 BD Horizon™ CD45RA (HI100) BV510
00382906666512 - Horizon2025-02-12 BD Horizon™ CD45RA (HI100) BV605

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.