Identity
- Trade Name
- GEM Hemochron 100 System FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory FDA UDI
- Device Name
- GEM Hemochron 100 System (Loaner) FDA UDI
- Model / Reference
- 000GH100L FDA UDI
- Description
- GEM Hemochron 100 System (Loaner) FDA UDI
Identifiers
- Catalog Number
- 000GH100L FDA UDI
- Primary DI / UDI-DI
- 10711234515044 FDA UDI
- 510(k) Number
- K202101 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Coagulation analyser IVD, laboratory 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulation analyser IVD, laboratoryCoagulation analyser IVD, point-of-care, line-powered
GEM Hemochron 100 System by Accriva Diagnostics Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation analyser IVD, point-of-care, line-powered.
- Quantra QPlus System — Hemosonics LLC · Class II
- Quantra QPlus System — Hemosonics LLC · Class II
- Quantra QPlus System — Hemosonics LLC · Class II
- Sonoclot® Coagulation & Platelet Function Analyzer — SIENCO, INC. · Class II
- Quantra QPlus System — Hemosonics LLC · Class II
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Coagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- Hemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
Cleared under the same submission
K202101 also covers:
- GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+) — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR) — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- directCHECK ACT+ Whole Blood Control Level 1 — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- directCHECK ACT+ Whole Blood Control, Level 2 — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- directCHECK ACT-LR Whole Blood Control, Level 2 — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- directCHECK ACT-LR Whole Blood Controls, Level 1 — ACCRIVA DIAGNOSTICS HOLDINGS, INC.
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 |
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Manufacturer
- Manufacturer
- Accriva Diagnostics Holdings, Inc.
Sources (1)
- FDA UDI a84c0202-7a78-43c0-8339-7897b3ba154b 36 fields · synced May 31, 2026