AccessGUDID - DEVICE: Trinity Biotech (05391516744218)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: System Wash Reagent - 940mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-03-0035
Company Name: PRIMUS CORPORATION

Primary DI Number: 05391516744218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790074793 *Terms of Use

Device Description: Hemoglobin A1c assay, System Wash Reagent - 940mL

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:	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?
53316	Glycated haemoglobin (HbA1c) 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 qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCP	Assay, Glycosylated Hemoglobin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K891235	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 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 940 Milliliter

Device Record Status

Public Device Record Key: 361f0f08-d84d-4156-9c29-b65d0d27374e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 06, 2016