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Tri-Combo Parasite Screen

FDA UDI

Class II (US FDA UDI)

by Techlab, Inc.

Identity

Trade Name
TRI-COMBO PARASITE SCREEN FDA UDI
Generic Name
Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
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. FDA UDI
Model / Reference
T5032 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00857031002547 FDA UDI
510(k) Number
K171078 FDA UDI
FDA Product Code
KHW FDA UDI
MHI FDA UDI
MHJ FDA UDI
GMDN Term
Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3220 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Tri-Combo Parasite Screen by Techlab, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K171078 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Techlab, Inc.

Sources (1)

  • FDA UDI 53648e1b-3105-4d20-b673-c7096d0ca3b7 35 fields · synced May 31, 2026