AccessGUDID - DEVICE: Spartan RX CYP2C19 System (00628055420095)

GUDID

Device Identifier (DI) Information

Brand Name: Spartan RX CYP2C19 System
Version or Model: 01004880-ABC (10)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01004880-ABC (10)
Company Name: Spartan Bioscience Inc

Primary DI Number: 00628055420095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243605917 *Terms of Use

Device Description: A box of 10 CYP2C19 External Control Kits.

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?
60091	Nucleic acid amplification mastermix kit IVD	A collection of reagents and other associated materials [enzymes, buffers, nucleotides, magnesium chloride (MgCl2)], intended to be used in combination with sequence-specific primers, probes and/or controls (not included) to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] in a clinical specimen, using a nucleic acid amplification technique [e.g., polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NSU	Instrumentation For Clinical Multiplex Test Systems
NTI	Drug Metabolizing Enzyme Genotyping Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123891	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: 16f574fc-31c4-44a7-86e0-e576bf6fa1b7
Public Version Date: April 18, 2025
Public Version Number: 4
DI Record Publish Date: September 26, 2016