Actalyke Thermometer

FDA UDI

Class I (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name: Actalyke Thermometer FDA UDI
Generic Name: Coagulation analyser IVD, laboratory FDA UDI
Model / Reference: 5757000 FDA UDI

Identifiers

Primary DI / UDI-DI: M52557570000 FDA UDI
FDA Product Code: LXG FDA UDI
GMDN Term: Coagulation analyser IVD, laboratory FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2050 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Coagulation analyser IVD, laboratory

Actalyke Thermometer by Helena Laboratories, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Helena Laboratories, Corp.

Sources (1)

FDA UDI a9a5ee35-70b1-43b1-9174-3a22878e932a 33 fields · synced Jun 9, 2026