AccessGUDID - DEVICE: Trinity Biotech (05391516741521)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: 203-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 203-A
Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY

Primary DI Number: 05391516741521
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 988298840 *Terms of Use

Device Description: G-6-PDH Deficiency (50 Tests)

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):	No
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?
55931	Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from a clinical specimen, using an enzyme spectrophotometry method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JBG	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Spot

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K933934	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
Device Size Text, specify: 50 Tests

Device Record Status

Public Device Record Key: 5946a5b0-4d10-4f56-b03c-8e80b436bc05
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016