LuMatic CLIA Analyzer IN008

GUDID 00816870020013

Chemiluminescent immunoassay analyser IVD

Primary Device ID	00816870020013
NIH Device Record Key	b175a9e7-b57f-4aeb-b8cf-984d6e130b23
Commercial Distribution Status	In Commercial Distribution
Brand Name	LuMatic CLIA Analyzer
Version Model Number	IN008
Catalog Number	IN008
Company DUNS	083155515
Company Name	MONOBIND, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00816870020013 [Primary]

JJQ	COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE

Steralize Prior To Use	false
Device Is Sterile	false

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