Parasite Suspensions

Basic Information

• Brand Name: Parasite Suspensions
• Primary DI: 10845357035100
• Version / Model: FP05
• Catalog Number: FP05
• Company Name: MICROBIOLOGICS INC.
• Labeler DUNS: 060467826
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 1
• Public Version Date: 2020-05-08
• Public Version Status: New
• Public Device Record Key: 561955cb-9c4b-45ce-a2d9-edd36a45e806

Device Description

Parasite Suspensions Ascaris lumbricoides

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LIB	DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47360	Multiple faecal parasite antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10845357035100	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius