SED-CONNECT 693A-E SED+EA

GUDID M445693AESEDEA50PACK1

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.

MEDICAL CHEMICAL CORPORATION

Faecal parasite specimen concentration kit IVD
Primary Device IDM445693AESEDEA50PACK1
NIH Device Record Key13354ec3-da83-4990-9e88-2e194b6c70bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSED-CONNECT
Version Model Number693A-E SED+EA
Catalog Number693A-E SED+EA
Company DUNS008496861
Company NameMEDICAL CHEMICAL CORPORATION
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM445693AESEDEA50PACK0 [Unit of Use]
HIBCCM445693AESEDEA50PACK1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKSDevice, Parasite Concentration

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-07-08
Device Publish Date2016-09-20

On-Brand Devices [SED-CONNECT]

M445693ASAMPLE1SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from
M445693AFUNNEL1SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from
M445693AESEDEA50PACK1SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from
M445693A50PACK1SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from

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