AccessGUDID - DEVICE: Trinity Biotech (05391516748186)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: Ultra2 Resolution 500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-04-0078
Company Name: PRIMUS CORPORATION

Primary DI Number: 05391516748186
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, Ultra2 Resolution 500 kit

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:	Yes
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?
59807	Inherited haemoglobinopathy 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 to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.	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
No Device Sizes

Device Record Status

Public Device Record Key: ba6f8675-79ae-4e8a-94b7-7097b319ceea
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016