DEVICE: Wampole ColorCard® ASO (10859035006214)

Device Identifier (DI) Information

Wampole ColorCard® ASO
47050
In Commercial Distribution

ALERE NORTH AMERICA, LLC
10859035006214
GS1

50
826027364 *Terms of Use
No description.
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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
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FDA Product Code

[?]
Product Code Product Code Name
GTQ Antistreptolysin - Titer/Streptolysin O Reagent
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

0798e3ff-5b51-439e-b86d-b5e2ab895fd4
October 25, 2018
1
September 24, 2018
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00859035006217 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-877-441-7440
ts.scr@alere.com
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