AST / Polychem 180

Basic Information

• Brand Name: AST / Polychem 180
• Primary DI: 00817439020239
• Version / Model: AST505
• Catalog Number: AST505
• Company Name: Medtest Dx, Inc.
• Labeler DUNS: 070371210
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 4
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 2df258ac-7f3d-4390-95f7-7a6f03b50470

Device Description

For the quantitative determination of Aspartate Aminotransferase (AST) in human serum using the Poly-Chem 180 analyzer. 6 x 50 ml, 3 x 20 ml

Device Characteristics

• Single Use: No
• 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
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	862.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52954	Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total aspartate aminotransferase (AST) 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	00817439020239	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K941132	000

Storage Conditions

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