Actalyke Mini II, w/ Printer, w/o Battery, "CE 2009" (110V/220V)

GUDID M52557530010

Coagulation analyser IVD, laboratory

Primary Device ID	M52557530010
NIH Device Record Key	448171ce-7c55-4dc9-80ef-26e750f09555
Commercial Distribution Status	In Commercial Distribution
Brand Name	Actalyke Mini II, w/ Printer, w/o Battery, "CE 2009" (110V/220V)
Version Model Number	5753001
Company DUNS	836287433
Company Name	HELENA LABORATORIES CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	M52557530010 [Primary]

JBP	ACTIVATED WHOLE BLOOD CLOTTING TIME

Steralize Prior To Use	false
Device Is Sterile	false

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