DEVICE: BioPlex 2200 (00847865000826)
Device Identifier (DI) Information
BioPlex 2200
6633220
In Commercial Distribution
6633220
BIO-RAD LABORATORIES, INC.
6633220
In Commercial Distribution
6633220
BIO-RAD LABORATORIES, INC.
CD, BioPlex Anti-CCP 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? |
---|---|---|---|---|
54898 | Cyclic citrullinated peptide antibody (anti-CCP) IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of antibodies to cyclic citrullinated peptide (CCP) in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NHX | ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) |
JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE |
JJY | Multi-analyte controls, all kinds (assayed) |
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
41a6089a-4ec2-4c94-b957-6d229c0d74b6
July 29, 2021
4
September 12, 2016
July 29, 2021
4
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