BÜHLMANN ACE Kinetic

Basic Information

• Brand Name: BÜHLMANN ACE Kinetic
• Primary DI: EBUHKKACK20
• Version / Model: KK-ACK2
• Catalog Number: KK-ACK2
• Company Name: Bühlmann Laboratories AG
• Labeler DUNS: 481261006
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-27
• Public Version: 1
• Public Version Date: 2025-07-07
• Public Version Status: New
• Public Device Record Key: 66666c88-5853-4ad2-82be-c39457b5d780

Device Description

The BÜHLMANN ACE kinetic assay is intended for the direct and quantitative in vitro diagnostic determination of angiotensin converting enzyme (ACE) activity in serum samples by enzymatic assay.

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: 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
KQN	Radioassay, Angiotensin Converting Enzyme	Clinical Chemistry	862.1090	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52944	Angiotensin converting enzyme (ACE) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of angiotensin converting enzyme (ACE) 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	EBUHKKACK20	HIBCC

Storage Conditions

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