DEVICE: Origin Instant Drug Test (B778610133OD0)

Device Identifier (DI) Information

Origin Instant Drug Test
61013-3-OD
In Commercial Distribution
61013-3-OD
ORIGIN DIAGNOSTICS LLC
B778610133OD0
HIBCC

1
036225773 *Terms of Use
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-pH,SG,OX
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46994 Multiple drugs of abuse IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DKZ Enzyme Immunoassay, Amphetamine
DIS Enzyme Immunoassay, Barbiturate
JXM Enzyme Immunoassay, Benzodiazepine
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LAF Gas Chromatography, Methamphetamine
DJR Enzyme Immunoassay, Methadone
DJG Enzyme Immunoassay, Opiates
LCM Enzyme Immunoassay, Phencyclidine
CLOSE

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
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 39 and 86 Degrees Fahrenheit
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

cde335bb-a3da-4c07-88b3-80cae7ce10ea
June 10, 2022
3
March 06, 2020
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

[?]
1-800-440-6695
orders@origin.net
CLOSE