Identity
- Trade Name
- HemosIL AcuStar HIT-IgG (PF4-H) FDA UDI
- Generic Name
- Platelet factor 4 IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 1. HIT- IgG(PF4-H)Cartridges for 25 determinations (Cat No 0009800128) 2. HIT-IgG (PF4-H) Calibaratior 1 (Cat No 0009800129) 3. HIT-IgG (PF4-H) Calibaratior 2 (Cat No 0009800130) FDA UDI
- Model / Reference
- 0009800127 FDA UDI
- Description
- 1. HIT- IgG(PF4-H)Cartridges for 25 determinations (Cat No 0009800128) 2. HIT-IgG (PF4-H) Calibaratior 1 (Cat No 0009800129) 3. HIT-IgG (PF4-H) Calibaratior 2 (Cat No 0009800130) FDA UDI
Identifiers
- Catalog Number
- 00009800127 FDA UDI
- Primary DI / UDI-DI
- 08426951126545 FDA UDI
- 510(k) Number
- K170854 FDA UDI
- FDA Product Code
- LCO FDA UDI
- GMDN Term
- Platelet factor 4 IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7695 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, kit, enzyme immunoassay (EIA)
HemosIL AcuStar HIT-IgG (PF4-H) 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, kit, enzyme immunoassay (EIA).
- PF4 Enhanced® — Immucor GTI Diagnostics, Inc. · Class II
- PF4 Enhanced® — Immucor GTI Diagnostics, Inc. · Class II
- PF4 IgG — Immucor GTI Diagnostics, Inc. · Class II
- PF4 IgG — Immucor GTI Diagnostics, Inc. · Class II
- HemosIL HIT-Ab(PF4-H) — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (2)
- FDA UDI f15d49df-94ef-47d5-a5b1-07ff103d6f40 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026