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BÜHLMANN ACE Kinetic

FDA UDI

Class II (US FDA UDI)

by Bühlmann Laboratories AG

Identity

Trade Name
BÜHLMANN ACE Kinetic FDA UDI
Generic Name
Angiotensin converting enzyme (ACE) IVD, kit, spectrophotometry FDA UDI
Device Name
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. FDA UDI
Model / Reference
KK-ACK2 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
KK-ACK2 FDA UDI
Primary DI / UDI-DI
EBUHKKACK20 FDA UDI
FDA Product Code
KQN FDA UDI
GMDN Term
Angiotensin converting enzyme (ACE) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1090 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Angiotensin converting enzyme (ACE) IVD, kit, spectrophotometry

BÜHLMANN ACE Kinetic by Bühlmann Laboratories AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bühlmann Laboratories AG

Sources (1)

  • FDA UDI 66666c88-5853-4ad2-82be-c39457b5d780 35 fields · synced May 30, 2026