DEVICE: Wampole ColorCard® Streptozyme® (10859035006221)
Device Identifier (DI) Information
Wampole ColorCard® Streptozyme®
46050
In Commercial Distribution
ALERE NORTH AMERICA, LLC
46050
In Commercial Distribution
ALERE NORTH AMERICA, LLC
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
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? |
---|---|---|---|---|
51719 | Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutination |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to extracellular antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using an agglutination method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GTY | Antigens, All Groups, Streptococcus Spp. |
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: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
f8aff050-c047-49dc-a796-02ca1f24114b
October 25, 2018
1
September 24, 2018
October 25, 2018
1
September 24, 2018
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:
00859035006224
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-877-441-7440
ts.scr@alere.com
ts.scr@alere.com