DEVICE: ARCHITECT (00380740001827)
Device Identifier (DI) Information
ARCHITECT
1P35-25
In Commercial Distribution
01P3525
ABBOTT LABORATORIES
1P35-25
In Commercial Distribution
01P3525
ABBOTT LABORATORIES
ARCHITECT iValproic Acid Reagent Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
61036 | Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay |
A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug valproic acid in a clinical specimen, using a chemiluminescent immunoassay method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DLJ | CALIBRATORS, DRUG SPECIFIC |
LEG | ENZYME IMMUNOASSAY, VALPROIC ACID |
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 |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3218f2d6-2c37-40b6-8f1d-f30d0a87a6ea
March 29, 2018
2
June 06, 2016
March 29, 2018
2
June 06, 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(877)422-2688
xx@xx.xx
xx@xx.xx