DEVICE: Ig Reagent Rb F(ab')2/APC (05700572018735)
Device Identifier (DI) Information
Ig Reagent Rb F(ab')2/APC
X0998
In Commercial Distribution
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
X0998
In Commercial Distribution
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Ig Reagent Rabbit F(ab')2/APC
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? |
---|---|---|---|---|
53786 | Total immunoglobulin G (IgG total) IVD, reagent |
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MVU | Reagents, specific, analyte |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify: Keep away from sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 1 Milliliter |
Device Record Status
fcb7646d-0d16-49ca-b44f-e22c787f9dd2
December 07, 2020
2
September 17, 2020
December 07, 2020
2
September 17, 2020
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
[?]
+4544859500
dako.dkregulatory@agilent.com
dako.dkregulatory@agilent.com