DEVICE: AgaMatrix (00385543764023)

Device Identifier (DI) Information

AgaMatrix
8000-03764
In Commercial Distribution

AGAMATRIX, INC.
00385543764023
GS1

1
156756129 *Terms of Use
Control Solution, AgaMatrix, Combo Normal and High
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Device Characteristics

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

GMDN

[?]

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

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

[?]
Product Code Product Code Name
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K103544 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 36 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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

8f466ef0-8a8d-40cf-afd8-1e31aa1d0489
July 06, 2018
3
November 04, 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
20385543764027 48 00385543764023 In Commercial Distribution Shipper
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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

[?]
1-866-906-4197
customerservice@agamatrix.com
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