DEVICE: ARCHITECT (00380740003289)

Device Identifier (DI) Information

ARCHITECT
2K43-10
In Commercial Distribution
02K4310
ABBOTT LABORATORIES
00380740003289
GS1

1
079226220 *Terms of Use
ARCHITECT STAT Myoglobin Controls
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
No
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Myoglobin IVD, control A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of myoglobin in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
JJY Multi-analyte controls, all kinds (assayed)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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 -.1 Degrees Celsius
Storage Environment Temperature: less than -10 Degrees Celsius
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Clinically Relevant Size

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

783aa71d-bbbe-4e54-8780-44fb2fb7c9e8
March 29, 2018
2
June 06, 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

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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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