AccessGUDID - DEVICE: GIARDIA/CRYPTOSPORIDIUM QUIK CHEK (00857031002165)

GUDID

Device Identifier (DI) Information

Brand Name: GIARDIA/CRYPTOSPORIDIUM QUIK CHEK
Version or Model: T30407
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECHLAB, INC.

Primary DI Number: 00857031002165
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 QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Giardia cyst antigen and Cryptosporidium oocyst antigen in a single test device. It is intended for use with human fecal specimens from patients with gastrointestinal symptoms to aid in the diagnosis of Giardia and/or Cryptosporidium gastrointestinal infection. The test results should be considered in conjunction with the patient history.

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
MHI	Giardia Spp.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103673	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: c46211fa-6701-479d-9f37-b25c1abbf9d9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 20, 2016