Identity
- Trade Name
- ACL TOP CTS FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory FDA UDI
- Device Name
- ACL TOP CTS (Refurbished) FDA UDI
- Model / Reference
- 00000280020R FDA UDI
- Description
- ACL TOP CTS (Refurbished) FDA UDI
Identifiers
- Catalog Number
- 00000280020R FDA UDI
- Primary DI / UDI-DI
- 08426950451600 FDA UDI
- 510(k) Number
- K160276 FDA UDI
- FDA Product Code
- GKP FDA UDI
- GMDN Term
- Coagulation analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5400 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulation analyser IVD, laboratory
Acl Top Cts by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation analyser IVD, laboratory.
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
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- QStat Cartridge — Hemosonics LLC
- TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION · Class II
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Helena Electronic Clotting Tube — Helena Laboratories, Corp. · Class I
- Actalyke Thermometer — Helena Laboratories, Corp. · Class I
Cleared under the same submission
K160276 also covers:
- ACL TOP 300 CTS — INSTRUMENTATION LABORATORY COMPANY
- ACL TOP 300 CTS — INSTRUMENTATION LABORATORY COMPANY
- ACL TOP 500 CTS — INSTRUMENTATION LABORATORY COMPANY
- ACL TOP 500 CTS — INSTRUMENTATION LABORATORY COMPANY
- ACL TOP 700 — INSTRUMENTATION LABORATORY COMPANY
- ACL TOP 700 — INSTRUMENTATION LABORATORY COMPANY
- ACL TOP 700 CTS — INSTRUMENTATION LABORATORY COMPANY
- ACL TOP 700 CTS — INSTRUMENTATION LABORATORY COMPANY
- ACL TOP 700 LAS — INSTRUMENTATION LABORATORY COMPANY
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI 7e30514e-ca37-4bda-9234-0d77606a088f 36 fields · synced Jun 8, 2026