POSITIVE CONTROL KIT

Basic Information

• Brand Name: POSITIVE CONTROL KIT
• Primary DI: 08056040141168
• Version / Model: POSITIVE CONTROL KIT
• Catalog Number: SI 190.911
• Company Name: ALIFAX SRL
• Labeler DUNS: 435930630
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-06
• Public Version: 1
• Public Version Date: 2022-10-14
• Public Version Status: New
• Public Device Record Key: 19200f8d-3555-4bbd-acef-1a712f8b9f65

Device Characteristics

• Single Use: No
• 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
JTA	Monitor, Microbial Growth	Microbiology	866.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63319	General microbial isolate identification control IVD	A substance containing a viable microorganism intended to be used to verify the performance of an assay or culture medium used in microbial testing for the identification of a microorganism isolated from a clinical specimen; it is not specific to any particular microbial assay. The microbial strain is typically impregnated on a suitable material (e.g., paper), air-dried and fixed onto a slide, or freeze-dried into a pellet, and may include accessories (e.g., swab, inoculating fluid).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056040141168	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius