DEVICE: BD Macro-Vue™ Card Test Rotator (00382902780519)
Device Identifier (DI) Information
BD Macro-Vue™ Card Test Rotator
278051
In Commercial Distribution
278051
BECTON, DICKINSON AND COMPANY
278051
In Commercial Distribution
278051
BECTON, DICKINSON AND COMPANY
BD Macro-Vue™ Card Test Rotator
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
51819 | Treponema pallidum reagin antibody IVD, kit, agglutination |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -25 and 65 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Depth: 8 Inch |
Width: 7 Inch |
Height: 5.25 Inch |
Device Record Status
15ce7747-e9a7-4654-a1f0-e2f5021d8a6a
December 05, 2023
4
May 19, 2016
December 05, 2023
4
May 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)638-8663
Technical_services@bd.com
Technical_services@bd.com