DEVICE: ARCHITECT (00380740156305)

Device Identifier (DI) Information

ARCHITECT
06K4604
In Commercial Distribution
06K4604
ABBOTT LABORATORIES
00380740156305
GS1

1
079226220 *Terms of Use
Quantia ASO Calibrator
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
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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: less than 29 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Do not freeze.
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Clinically Relevant Size

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

4c2c2a63-88e5-473e-9118-aa4306adf95b
September 21, 2023
2
March 03, 2020
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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
No
No CLOSE

Customer Contact

[?]
+1(877)422-2688
xx@xx.xx
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