PARA-SED 695A-EA

GUDID M445695AEA1

PARA-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This kit contains 50 sets of single use components and ethyl acetate as an additional reagent.

MEDICAL CHEMICAL CORPORATION

Faecal parasite specimen concentration kit IVD

• Primary Device ID: M445695AEA1
• NIH Device Record Key: 6ab1ff91-56d3-48de-9fed-9d96c06fb639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARA-SED
• Version Model Number: 695A-EA
• Catalog Number: 695A-EA
• Company DUNS: 008496861
• Company Name: MEDICAL CHEMICAL CORPORATION
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M445695AEA0 [Unit of Use]
HIBCC	M445695AEA1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941129

FDA Product Code

• LKS: Device, Parasite Concentration

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-08
• Device Publish Date: 2016-09-20

On-Brand Devices [PARA-SED]

• M445695ASAMPLE1: PARA-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from pr
• M445695AEA1: PARA-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from pr
• M445695A1: PARA-SED is a closed concentration system for the recovery of eggs, larvae, and protozoa from pr