AccessGUDID - DEVICE: Rapid Response (00722066004593)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid Response
Version or Model: D10.22-1P29-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BTNX Inc

Primary DI Number: 00722066004593
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 251005005 *Terms of Use

Device Description: 10-Drug Test Panel - 25/kit(10.22) - COC300 AMP1000 MET1000 THC50 MTD300 MOP300 OXY100 BAR300 BZO300 BUP10

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):	No
Over the Counter (OTC):	Yes
Kit:	No
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
PTH	Test, Barbiturate, Over The Counter
PTG	Test, Methadone, Over The Counter
NGL	Test, Opiates, Over The Counter
NGG	Test, Methamphetamine, Over The Counter
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter
NFW	Test, Cannabinoid, Over The Counter
NFV	Test, Benzodiazepine, Over The Counter
NFT	Test, Amphetamine, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180349	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: 16a982ae-c0de-4405-ba63-0c7c4ec24fb9
Public Version Date: April 20, 2023
Public Version Number: 4
DI Record Publish Date: February 06, 2019