DEVICE: Teco Diagnostics Cholinesterase Reagent Set (10673486001488)

Device Identifier (DI) Information

Teco Diagnostics Cholinesterase Reagent Set
C511-60
In Commercial Distribution
C511-60
TECO DIAGNOSTICS
10673486001488
GS1

1
185067774 *Terms of Use
Teco Diagnostics Cholinesterase Reagent Set is used for in vitro diagnostic use in the quantitative kinetic determination of cholinesterase in human serum, plasma, or whole blood.
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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?
52981 Cholinesterase dibucaine number (percentage inhibition) IVD, reagent
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the dibucaine number or percentage inhibition of cholinesterase activity by dibucaine in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DIH Colorimetry, Cholinesterase
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K914171 000
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Sterilization

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

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

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Size Type Text
No Device Sizes
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Device Record Status

053e590f-aa62-4040-b7e9-5f9e68d61372
August 03, 2023
1
July 26, 2023
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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

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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

[?]
714-463-1111
hello@tecodiagnostics.com
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