Identity
- Trade Name
- HemosIL Acustar HIT Controls FDA UDI
- Generic Name
- Platelet factor 4 IVD, control FDA UDI
- Device Name
- 1. Low HIT Control (Cat. No. 00009800132) 2. High HIT Control (Cat. No. 00009800133): FDA UDI
- Model / Reference
- 0009800131 FDA UDI
- Description
- 1. Low HIT Control (Cat. No. 00009800132) 2. High HIT Control (Cat. No. 00009800133): FDA UDI
Identifiers
- Catalog Number
- 00009800131 FDA UDI
- Primary DI / UDI-DI
- 08426951126538 FDA UDI
- 510(k) Number
- K170854 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Platelet factor 4 IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 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
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: Platelet factor 4 IVD, control
HemosIL Acustar HIT Controls by Instrumentation Laboratory Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Platelet factor 4 IVD, control.
- Negative Serum Control — Immucor GTI Diagnostics, Inc. · Class II
- Positive Serum Control — Immucor GTI Diagnostics, Inc. · Class II
- HemosIL HIT-Ab(PF4-H) Controls — INSTRUMENTATION LABORATORY COMPANY · Class II
Cleared under the same submission
K170854 also covers:
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 0da3a107-e330-40f7-9d53-f42818021d4c 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026