CLA-1™ Luminometer 95019

GUDID 00813382010044

Chemiluminescent immunoassay analyser IVD, semi-automated

Primary Device ID	00813382010044
NIH Device Record Key	e6537bc3-1b8e-4a23-9e76-8c5ae234a495
Commercial Distribution Status	In Commercial Distribution
Brand Name	CLA-1™ Luminometer
Version Model Number	95019
Catalog Number	95019
Company DUNS	102113867
Company Name	HITACHI CHEMICAL DIAGNOSTICS, INC.
Device Count	1
DM Exempt	true
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
GS1	00813382010044 [Primary]

DHB	SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL

Steralize Prior To Use	false
Device Is Sterile	false

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