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Giardia/Cryptosporidium Quik Chek

FDA UDI

Class II (US FDA UDI)

by Techlab, Inc.

Identity

Trade Name
GIARDIA/CRYPTOSPORIDIUM QUIK CHEK FDA UDI
Generic Name
Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
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. FDA UDI
Model / Reference
T30407 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00857031002165 FDA UDI
510(k) Number
K103673 FDA UDI
FDA Product Code
MHI 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
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

Yes

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

Category: Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)

Giardia/Cryptosporidium Quik Chek by Techlab, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Techlab, Inc.

Sources (1)

  • FDA UDI c46211fa-6701-479d-9f37-b25c1abbf9d9 34 fields · synced May 30, 2026