DEVICE: ARCHITECT (00380740001377)
Device Identifier (DI) Information
ARCHITECT
1L77-25
In Commercial Distribution
01L7725
ABBOTT LABORATORIES
1L77-25
In Commercial Distribution
01L7725
ABBOTT LABORATORIES
ARCHITECT Tacrolimus 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? |
---|---|---|---|---|
61025 | Tacrolimus 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 immunosuppressant drug tacrolimus in a clinical specimen, using a chemiluminescent immunoassay method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MLM | ENZYME IMMUNOASSAY, TRACROLIMUS |
JIT | CALIBRATOR, SECONDARY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K070820 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
95260261-8664-477b-8b9c-30e2c331181f
December 14, 2023
4
June 06, 2016
December 14, 2023
4
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