Teg6s Hemostasis System

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name: TEG6S HEMOSTASIS SYSTEM FDA UDI
Generic Name: Multiple coagulation factor IVD, control FDA UDI
Device Name: BOX, 6S ABNORMAL QC KIT FDA UDI
Model / Reference: 07-662US FDA UDI
Description: BOX, 6S ABNORMAL QC KIT FDA UDI

Identifiers

Primary DI / UDI-DI: 10812747018340 FDA UDI
FDA Product Code: JOZ FDA UDI
GMDN Term: Multiple coagulation factor IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple coagulation factor IVD, control

Teg6s 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

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 af3f4634-667d-4f94-838e-099605d48463 35 fields · synced Jun 8, 2026