Identity
- Trade Name
- directCHECK ACT-LR Whole Blood Controls, Level 1 FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- directCHECK GH100 ACTLRL1 15/box. FDA UDI
- Model / Reference
- 000DCGLR-1 FDA UDI
- Description
- directCHECK GH100 ACTLRL1 15/box. FDA UDI
Identifiers
- Catalog Number
- 000DCGLR-1 FDA UDI
- Primary DI / UDI-DI
- 10711234170366 FDA UDI
- 510(k) Number
- K202101 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Multiple coagulation factor 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple coagulation factor IVD, control
directCHECK ACT-LR Whole Blood Controls, Level 1 by Accriva Diagnostics Holdings, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple coagulation factor IVD, control.
- Coagulation S.A.R.P (Specialty Assayed Reference Plasma) — Helena Laboratories, Corp. · Class II
- Dade Ci-Trol Coagulation Control Level 1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- CRYOcheck™ Abnormal 1 Reference Control — Precision Biologic · Class II
- JAS Diagnostics — Drew Scientific , Ltd.
- CueSee® Coag — Eurotrol B.V. · Class II
- COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) — Randox Laboratories, Ltd. · Class I
- IDG/Sanzay — IDG/SANZAY Corporation · 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.
- GEM Hemochron 100 System — 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.
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 d31961b1-71ad-4d16-bfb1-9d2668a7cfad 37 fields · synced Jun 8, 2026