DEVICE: Rheumajet ASO 100 TESTS (08426950457305)
Device Identifier (DI) Information
Rheumajet ASO 100 TESTS
3000-7010
In Commercial Distribution
BIOKIT, S.A.
3000-7010
In Commercial Distribution
BIOKIT, S.A.
2 x 2.5 ml REAGENT
1 x 1.5 ml CONTROL +
1 x 1.5 ml CONTROL –
2 x 9 SLIDES
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? |
---|---|---|---|---|
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 |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b5ba4884-7923-4ff6-b990-b47114f64dd6
March 29, 2018
2
September 23, 2016
March 29, 2018
2
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