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Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay

FDA UDI

Class II (US FDA UDI)

by Medical Chemical Corporation

Identity

Trade Name
Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay FDA UDI
Generic Name
Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT) FDA UDI
Device Name
The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium oocysts and Giardia cysts in human stool by direct immunofluorescence microscopy. This kit contains enough reagents for 75 tests. FDA UDI
Model / Reference
MCC-C/G-DFA 75 FDA UDI
Description
The Para-Tect Cryptosporidium/Giardia kit is intended to detect Cryptosporidium oocysts and Giardia cysts in human stool by direct immunofluorescence microscopy. This kit contains enough reagents for 75 tests. FDA UDI

Identifiers

Catalog Number
MCC-C/G-DFA 75 FDA UDI
Primary DI / UDI-DI
M445MCCCGDFA750 FDA UDI
510(k) Number
K024113 FDA UDI
FDA Product Code
MHI FDA UDI
MHJ FDA UDI
GMDN Term
Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT) 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

No

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, direct fluorescent test (DFT)

Para-Tect Cryptosporidium/Giardia Direct Fluorescence Assay by Medical Chemical Corporation — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple faecal parasite antigen IVD, kit, direct fluorescent test (DFT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Chemical Corporation

Sources (1)

  • FDA UDI 06f6a366-1c84-4c1a-a5f1-6c06dc00be0b 36 fields · synced Jun 9, 2026