Identity
- Trade Name
- ACL TOP 750 LAS FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory FDA UDI
- Device Name
- ACL TOP 750 LAS FDA UDI
- Model / Reference
- 00000280035 FDA UDI
- Description
- ACL TOP 750 LAS FDA UDI
Identifiers
- Catalog Number
- 00000280035 FDA UDI
- Primary DI / UDI-DI
- 08426950784050 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
Yes
FDA UDI
Category: Coagulation analyser IVD, laboratory
Acl Top 750 Las by Instrumentation Laboratory Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Coagulation analyser IVD, laboratory.
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- Actalyke Thermometer — Helena Laboratories, Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (2)
- FDA UDI f2199c58-9f89-4d03-b011-be9817915a81 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026