Actalyke XL, Dual Detection, (New Display) "CE" (110V/220V)

FDA UDI

Class II (US FDA UDI)

by Helena Laboratories, Corp.

Identity

Trade Name: Actalyke XL, Dual Detection, (New Display) "CE" (110V/220V) FDA UDI
Generic Name: Coagulation analyser IVD, laboratory FDA UDI
Model / Reference: 5770001 FDA UDI

Identifiers

Primary DI / UDI-DI: M52557700010 FDA UDI
510(k) Number: K020914 FDA UDI
FDA Product Code: JBP FDA UDI
GMDN Term: Coagulation analyser IVD, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7140 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Category: Coagulation analyser IVD, laboratory

A comprehensive medical device directory listing the Actalyke XL, Dual Detection (New Display), 'CE' (110V/220V) Coagulation analyser IVD. This device is a laboratory instrument used for qualitative and quantitative in vitro determination of coagulation components in haemostasis.

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Cleared under the same submission

K020914 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: Helena Laboratories, Corp.

Sources (1)

FDA UDI 48298471-135f-44ea-a024-05155dc10a3b 34 fields · synced Jul 15, 2026