DEVICE: BioPlex 2200 (00847865000031)
Device Identifier (DI) Information
BioPlex 2200
6631121
In Commercial Distribution
6631121
BIO-RAD LABORATORIES, INC.
6631121
In Commercial Distribution
6631121
BIO-RAD LABORATORIES, INC.
ANA Screen Calibrator Lot Data
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
41270 | Multiple antinuclear antibody (ANA) screening IVD, calibrator |
A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
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
0d70236d-3c24-4eb9-a2b9-0c536fd2b0e2
July 29, 2021
5
September 12, 2016
July 29, 2021
5
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