DEVICE: ARCHITECT (00380740003500)
Device Identifier (DI) Information
ARCHITECT
2K48-10
In Commercial Distribution
02K4810
ABBOTT LABORATORIES
2K48-10
In Commercial Distribution
02K4810
ABBOTT LABORATORIES
ARCHITECT T-Uptake Controls
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? |
---|---|---|---|---|
54399 | Multiple thyroid hormone uptake (T-uptake) 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 the unbound/free portion of the unbound/free portion of multiple proteins [e.g., thyroxine binding globulin (TBG), transthyretin and/or albumin] associated with thyroid hormone uptake, in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIT | CALIBRATOR, SECONDARY |
JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) |
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 |
Handling Environment Temperature: less than 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
f1e33347-34b7-4ee4-992c-cd56a3bc6cbd
February 05, 2024
4
June 06, 2016
February 05, 2024
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