Identity
- Trade Name
- ACE Kinetic Kit FDA UDI
- Generic Name
- Angiotensin converting enzyme (ACE) IVD, reagent FDA UDI
- Device Name
- The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnostic determination of angiotensin converting enzyme (ACE) activity in serum by an enzymatic assay. FDA UDI
- Model / Reference
- KK-ACKX FDA UDI
- Description
- The BÜHLMANN ACE kinetic test is intended for the direct and quantitative in vitro diagnostic determination of angiotensin converting enzyme (ACE) activity in serum by an enzymatic assay. FDA UDI
Identifiers
- Catalog Number
- KK-ACKX FDA UDI
- Primary DI / UDI-DI
- EBUHKKACKX1 FDA UDI
- 510(k) Number
- K913091 FDA UDI
- FDA Product Code
- KQN FDA UDI
- GMDN Term
- Angiotensin converting enzyme (ACE) IVD, reagent 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
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, reagent
ACE Kinetic Kit by Bühlmann Laboratories AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Angiotensin converting enzyme (ACE) IVD, reagent.
- ACE Liquid — Sentinel Ch. Srl · Class II
- Trinity Biotech — TRINITY BIOTECH PUBLIC LIMITED COMPANY · Class II
- Thermo Scientific Infinity™ — Fisher Diagnostics · Class II
- ACE Reagent — Sentinel Ch. Srl · Class II
- ACE Reagent — Sentinel Ch. Srl · Class II
- ACE Kinetic Kit — Bühlmann Laboratories AG · Class II
- ACE Kinetik Kit — Bühlmann Laboratories AG · Class II
Cleared under the same submission
K913091 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bühlmann Laboratories AG
Sources (1)
- FDA UDI d0aad679-e8bb-4589-947a-1664d3793396 37 fields · synced Jun 6, 2026