DEVICE: Oxycodone Enzyme Immunoassay (B0760241B0)

Device Identifier (DI) Information

Oxycodone Enzyme Immunoassay
0241b
In Commercial Distribution
0241b
LIN-ZHI INTERNATIONAL, INC.
B0760241B0
HIBCC

1
840839190 *Terms of Use
Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
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
Oxycodone 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 oxycodone in a clinical specimen, using an enzyme immunoassay (EIA) method.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DJG Enzyme Immunoassay, Opiates
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K120763 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

96a37860-f8fa-47c5-8109-13941baaee48
August 24, 2018
4
July 05, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE