AccessGUDID - DEVICE: Trinity Biotech (05391516744201)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: Genesys 2 Reagent - 3.8L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-03-0022
Company Name: PRIMUS CORPORATION

Primary DI Number: 05391516744201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790074793 *Terms of Use

Device Description: Hemoglobin variants assay, Genesys 2 Reagent - 3.8L

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?
55879	Multiple haemoglobin subtype 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 determination of multiple subtypes of haemoglobin in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKA	Abnormal Hemoglobin Quantitation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K955283	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: 3.8 Liter

Device Record Status

Public Device Record Key: b327ecd0-7275-441c-a1e1-64f74b3c5e58
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 06, 2016