AccessGUDID - DEVICE: TRI-COMBO PARASITE SCREEN (00857031002547)

GUDID

Device Identifier (DI) Information

Brand Name: TRI-COMBO PARASITE SCREEN
Version or Model: T5032
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TECHLAB, INC.

Primary DI Number: 00857031002547
Issuing Agency: GS1
Commercial Distribution End Date: August 02, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 614218634 *Terms of Use

Device Description: The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.

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:	No
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
KHW	Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
MHI	Giardia Spp.
MHJ	Cryptosporidium Spp.

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171078	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: 53648e1b-3105-4d20-b673-c7096d0ca3b7
Public Version Date: August 15, 2023
Public Version Number: 2
DI Record Publish Date: May 31, 2019