DEVICE: ARCHITECT (00380740003647)
Device Identifier (DI) Information
ARCHITECT
2K98-10
In Commercial Distribution
02K9810
ABBOTT LABORATORIES
2K98-10
In Commercial Distribution
02K9810
ABBOTT LABORATORIES
Microalbumin Controls
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Microalbumin IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JIS | CALIBRATOR, PRIMARY |
JJX | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) |
JIQ | TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K030320 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 10 Degrees Celsius |
Special Storage Condition, Specify: Do not freeze. |
Handling Environment Temperature: less than 29 Degrees Celsius |
Handling Environment Humidity: exactly 0 Percent (%) Relative Humidity |
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3ab10404-dfcf-4a8b-b4c3-ad6b3c4513e9
July 06, 2018
3
September 09, 2016
July 06, 2018
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