Sed-Connect

FDA UDI

Class I (US FDA UDI)

by Medical Chemical Corporation

Identity

Trade Name: SED-CONNECT FDA UDI
Generic Name: Faecal parasite specimen concentration kit IVD FDA UDI
Device Name: SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This kit contains ethyl acetate as an additional reagent. This kit contains 50 single use sets of devices. FDA UDI
Model / Reference: 693A-E SED+EA FDA UDI
Description: SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This kit contains ethyl acetate as an additional reagent. This kit contains 50 single use sets of devices. FDA UDI

Identifiers

Catalog Number: 693A-E SED+EA FDA UDI
Primary DI / UDI-DI: M445693AESEDEA50PACK1 FDA UDI
510(k) Number: K941129 FDA UDI
FDA Product Code: LKS FDA UDI
GMDN Term: Faecal parasite specimen concentration kit IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 866.2900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Faecal parasite specimen concentration kit IVD

Sed-Connect by Medical Chemical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Medical Chemical Corporation

Sources (1)

FDA UDI 13354ec3-da83-4990-9e88-2e194b6c70bc 35 fields · synced Jun 9, 2026