FastPack® Control Kit

Basic Information

• Brand Name: FastPack® Control Kit
• Primary DI: 00816467020136
• Version / Model: Multi-Analyte Controls
• Catalog Number: 25000056
• Company Name: QUALIGEN INC.
• Labeler DUNS: 959103565
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 699d9a1e-dcc9-4a53-b7a1-4cd9317facb0

Device Description

Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30213	Multiple clinical chemistry enzyme IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple clinical chemistry enzymes. Analytes detected may include alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816467020136	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123725	000

Storage Conditions

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