Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Angiotensin converting enzyme (ACE) IVD, control FDA UDI
- Device Name
- ACE CONTROL-N FDA UDI
- Model / Reference
- A6040 FDA UDI
- Description
- ACE CONTROL-N FDA UDI
Identifiers
- Catalog Number
- A6040 FDA UDI
- Primary DI / UDI-DI
- 05391516747233 FDA UDI
- 510(k) Number
- K860453 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Angiotensin converting enzyme (ACE) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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, control
Trinity Biotech by Clark Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Angiotensin converting enzyme (ACE) IVD, control.
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- ACE Control — Sentinel Ch. Srl · Class I
- ACE Elevated Control — Analytical Control Systems · Class I
- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
Cleared under the same submission
K860453 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 I | Pending data |
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Manufacturer
- Manufacturer
- Clark Laboratories, Inc.
Sources (1)
- FDA UDI e352408a-be98-411b-9534-4bafeb8707d1 38 fields · synced Jun 6, 2026