DEVICE: BioPlex 2200 (00847865010924)
Device Identifier (DI) Information
BioPlex 2200
SW4.1_v1
In Commercial Distribution
6651470E
BIO-RAD LABORATORIES, INC.
SW4.1_v1
In Commercial Distribution
6651470E
BIO-RAD LABORATORIES, INC.
Syphilis IgG Assay Protocol File CD, SW4.1_v1
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
51805 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 1 Each |
Device Record Status
f5548cfb-a1df-4a7e-8e6e-7581cd9abc30
March 29, 2018
2
September 12, 2016
March 29, 2018
2
September 12, 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 |
---|---|
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)224-6723
TechSupport.USSD@bio-rad.com
TechSupport.USSD@bio-rad.com