AccessGUDID - DEVICE: Trinity Biotech (05391516746359)

GUDID

Device Identifier (DI) Information

Brand Name: Trinity Biotech
Version or Model: 1206621
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1206621
Company Name: MARDX DIAGNOSTICS, INC.

Primary DI Number: 05391516746359
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154281349 *Terms of Use

Device Description: Uni-Gold™ Cryptosporidium Control, Cryptosporidium Positive and Negative Control, 1 Positive and 1 Negative

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:	Yes
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?
44026	Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Cryptosporidium parvum in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHJ	Cryptosporidium Spp.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121565	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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c5732007-f6d0-4670-a17a-3e34f3edc283
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 18, 2016