Teg5000 Hemostasis System

FDA UDI

Class II (US FDA UDI)

by Haemonetics Corporation

Identity

Trade Name: TEG5000 HEMOSTASIS SYSTEM FDA UDI
Generic Name: Platelet aggregation study IVD, reagent FDA UDI
Device Name: PLATELETMAPPING MULTIPAK ADP & AA FDA UDI
Model / Reference: 07-040 FDA UDI
Description: PLATELETMAPPING MULTIPAK ADP & AA FDA UDI

Identifiers

Primary DI / UDI-DI: 20812747018101 FDA UDI
510(k) Number: K041502 FDA UDI
FDA Product Code: JOZ FDA UDI
GMDN Term: Platelet aggregation study IVD, reagent 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

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: Platelet aggregation study IVD, reagent

Teg5000 Hemostasis System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Platelet aggregation study IVD, reagent.

Plateletworks ADP Kit — Helena Laboratories, Corp. · Class II
Dade® PFA Collagen/ADP Test Cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Collagen Reagent — Helena Laboratories, Corp. · Class II
VerifyNow Platelet Reactivity Test — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
Platelet Aggregation Kit — Helena Laboratories, Corp. · Class II
ADP Reagent — Helena Laboratories, Corp. · Class II
VerifyNow Platelet Reactivity Test — ACCRIVA DIAGNOSTICS HOLDINGS, INC. · Class II
Plateletworks Collagen Kit — Helena Laboratories, Corp. · Class II

Cleared under the same submission

K041502 also covers:

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 816ff69e-f56c-4bf2-abc5-1ea77ff28c2a 36 fields · synced Jun 8, 2026