Para-Pak Macro-CON 970120

GUDID 00840733102028

Para-Pak Macro-CON is a system for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. The filtration unit is designed to be used directly with the Para-Pak specimen collection vial. This creates a completely closed system, minimizing exposure of the user to potentially infectious agents. Macro-CON concentration utilizes the entire contents of the Para-Pak specimen collection vial, reducing variation due to specimen sampling. This is of particular advantage to the clinical parasitologist when a small number of organisms may be present in a large volume of stool.

MERIDIAN BIOSCIENCE, INC.

Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD Faecal parasite isolation kit IVD
Primary Device ID00840733102028
NIH Device Record Keyf258bd59-14cc-4586-816b-d0756c2d8076
Commercial Distribution StatusIn Commercial Distribution
Brand NamePara-Pak Macro-CON
Version Model Number970120
Catalog Number970120
Company DUNS092815364
Company NameMERIDIAN BIOSCIENCE, INC.
Device Count1
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

Customer Support Contacts

Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com
Phone513-271-3700
Emailinfo@meridianbioscience.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733102028 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-03
Device Publish Date2020-10-26

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