DEVICE: IMMAGE (15099590233242)

Device Identifier (DI) Information

IMMAGE
447480
In Commercial Distribution
447480
Beckman Coulter, Inc.
15099590233242
GS1

1
008254708 *Terms of Use
IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent
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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?
51728 Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to DNAse B enzyme produced by Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GTR Antideoxyribonuclease, Streptococcus Spp.
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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
No storage/handling found
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Clinically Relevant Size

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

13b3a54c-2b52-489f-9ae0-3b03fb8c8ac7
March 29, 2018
2
August 24, 2016
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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