AccessGUDID - DEVICE: Teco Diagnostics Cholinesterase Reagent Set (10673486001488)

GUDID

Device Identifier (DI) Information

Brand Name: Teco Diagnostics Cholinesterase Reagent Set
Version or Model: C511-60
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C511-60
Company Name: TECO DIAGNOSTICS

Primary DI Number: 10673486001488
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 185067774 *Terms of Use

Device Description: Teco Diagnostics Cholinesterase Reagent Set is used for in vitro diagnostic use in the quantitative kinetic determination of cholinesterase in human serum, plasma, or whole blood.

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:	No
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?
52981	Cholinesterase dibucaine number (percentage inhibition) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the dibucaine number or percentage inhibition of cholinesterase activity by dibucaine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DIH	Colorimetry, Cholinesterase

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K914171	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 053e590f-aa62-4040-b7e9-5f9e68d61372
Public Version Date: August 03, 2023
Public Version Number: 1
DI Record Publish Date: July 26, 2023