Identity
- Trade Name
- TEG5000 HEMOSTASIS SYSTEM FDA UDI
- Generic Name
- Multiple coagulation factor IVD, control FDA UDI
- Device Name
- LEVEL I CONTROL FDA UDI
- Model / Reference
- 07-007 FDA UDI
- Description
- LEVEL I CONTROL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20812747018026 FDA UDI
- 510(k) Number
- K993678 FDA UDI
- FDA Product Code
- JPA 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
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: Multiple coagulation factor IVD, control
Teg5000 Hemostasis System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple coagulation factor IVD, control.
- directCHECK Whole Blood Controls — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
- 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
Cleared under the same submission
K993678 also covers:
- TEG HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION
- TEG5000 — HAEMONETICS CORPORATION
- TEG5000 — HAEMONETICS CORPORATION
- TEG5000 — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS ANALYZER — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS ANALYZER — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION
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
- Haemonetics Corporation
Sources (1)
- FDA UDI 92cad852-5532-465c-80ab-d11197f1d37e 36 fields · synced Jun 8, 2026