DEVICE: BioPlex 2200 (03610520506431)
Device Identifier (DI) Information
BioPlex 2200
12000880
In Commercial Distribution
12000880
BIO-RAD LABORATORIES, INC.
12000880
In Commercial Distribution
12000880
BIO-RAD LABORATORIES, INC.
BioPlex 2200 Lyme Total Control CD
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? |
---|---|---|---|---|
50570 | Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control |
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Borrelia burgdorferi bacteria in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJX | Single (specified) analyte controls (assayed and unassayed) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K183446 | 000 |
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
9bf3f6ba-f704-4c76-8964-7e2f7db86f24
May 08, 2019
1
April 30, 2019
May 08, 2019
1
April 30, 2019
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