DEVICE: ASO Titer Control (08426950590453)
Device Identifier (DI) Information
ASO Titer Control
300021060
Not in Commercial Distribution
BIOKIT, S.A.
300021060
Not in Commercial Distribution
BIOKIT, S.A.
2 x 0.5 ml titrated control
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
51745 | Beta-haemolytic Group A Streptococcus streptolysin O antibody 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 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 |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
0f6c68f7-35ce-4eb1-8983-9ad6ac04d27b
July 17, 2025
4
September 23, 2016
July 17, 2025
4
September 23, 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
[?]
1-800-926-3353
support@inovadx.com
support@inovadx.com