AccessGUDID - DEVICE: Rapid Response (00722066003701)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid Response
Version or Model: D12.1-1G29-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D12.1-1G29-25
Company Name: BTNX Inc

Primary DI Number: 00722066003701
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 251005005 *Terms of Use

Device Description: Rapid Response Multi Drug Integrated Split Specimen Cups (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Morphine, Oxycodone, Propoxyphene, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
DJG	Enzyme Immunoassay, Opiates
DIS	Enzyme Immunoassay, Barbiturate
LCM	Enzyme Immunoassay, Phencyclidine
JXN	Enzyme Immunoassay, Propoxyphene
DKZ	Enzyme Immunoassay, Amphetamine
JXM	Enzyme Immunoassay, Benzodiazepine
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LDJ	Enzyme Immunoassay, Cannabinoids
DJR	Enzyme Immunoassay, Methadone
DJC	Thin Layer Chromatography, Methamphetamine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121065	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 33c6356e-2bb9-407f-9a41-c129ee442cd4
Public Version Date: April 20, 2023
Public Version Number: 6
DI Record Publish Date: October 25, 2016