DEVICE: ARCHITECT (00380740014322)
Device Identifier (DI) Information
ARCHITECT
7K64-25
In Commercial Distribution
07K6425
ABBOTT IRELAND
7K64-25
In Commercial Distribution
07K6425
ABBOTT IRELAND
ARCHITECT Total T3 Reagent Kit (100T)
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? |
---|---|---|---|---|
58330 | Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of total triiodothyronine (TT3) in a clinical specimen, using a chemiluminescent immunoassay method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE |
JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) |
JIT | CALIBRATOR, SECONDARY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 2 and 8 Degrees Celsius |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a3b8e91c-02a2-4606-9e3d-737942d1d582
October 09, 2023
3
September 09, 2016
October 09, 2023
3
September 09, 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