AccessGUDID - DEVICE: GIARDIA/CRYPTOSPORIDIUM CHEK (00857031002240)

GUDID

Device Identifier (DI) Information

Brand Name: GIARDIA/CRYPTOSPORIDIUM CHEK
Version or Model: T5031
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECHLAB, INC.

Primary DI Number: 00857031002240
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 614218634 *Terms of Use

Device Description: The GIARDIA/CRYPTOSPORIDIUM CHEK test is an enzyme immunoassay for the qualitative detection of Giardia cyst and Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Giardia and/or Cryptosporidium gastrointestinal infections.

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):	Yes
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?
47356	Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHJ	Cryptosporidium Spp.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051929	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 357e22b6-a155-4441-8db5-9fd7946d0c76
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 23, 2016