DEVICE: Oral Fluid Methamphetamine Enzyme Immunoassay (B076S0051B0)

Device Identifier (DI) Information

Oral Fluid Methamphetamine Enzyme Immunoassay
S0051b
In Commercial Distribution
S0051b
LIN-ZHI INTERNATIONAL, INC.
B076S0051B0
HIBCC

1
840839190 *Terms of Use
Large Test Kit. Antibody/Substrate Reagent (R1): 750 mL. Enzyme Conjugate Reagent (R2): 375 mL.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Methamphetamine-specific 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 a specific methamphetamine in a clinical specimen, using an enzyme immunoassay (EIA) method.
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FDA Product Code

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Product Code Product Code Name
LAF Gas Chromatography, Methamphetamine
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131652 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

c9688d42-808c-414c-846f-db6a91bdf513
August 24, 2018
4
July 05, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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