GENCHEM™ Alkaline Phosphatase

Basic Information

• Brand Name: GENCHEM™ Alkaline Phosphatase
• Primary DI: 00851445007020
• Version / Model: GEN-ALP R1
• Catalog Number: GEN-ALP R1
• Company Name: GENCHEM INC
• Labeler DUNS: 193856866
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 5
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: afc3b7e3-f19b-4674-ba0c-fbdb9dc22a5c
• Distribution End Date: 2020-08-19

Device Description

10/17/2022

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
CJE	NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES	Clinical Chemistry	862.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52930	Alkaline phosphatase (ALP) isoenzyme IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple alkaline phosphatase (ALP) isoenzymes in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851445007020	GS1

Customer Contacts

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