DEVICE: ARCHITECT (00380740156305)
Device Identifier (DI) Information
ARCHITECT
06K4604
In Commercial Distribution
06K4604
ABBOTT LABORATORIES
06K4604
In Commercial Distribution
06K4604
ABBOTT LABORATORIES
Quantia ASO Calibrator
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? |
---|---|---|---|---|
51744 | Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of antibodies to streptolysin O enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GTQ | ANTISTREPTOLYSIN - TITER/STREPTOLYSIN O REAGENT |
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: less than 29 Degrees Celsius |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Special Storage Condition, Specify: Do not freeze. |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
4c2c2a63-88e5-473e-9118-aa4306adf95b
September 21, 2023
2
March 03, 2020
September 21, 2023
2
March 03, 2020
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