NeoLumax CLIA Analyzer IN010

GUDID 00816870020006

Chemiluminescent immunoassay analyser IVD

Primary Device ID	00816870020006
NIH Device Record Key	309e30c2-91da-40ad-9fd1-b6d38a73b59a
Commercial Distribution Status	In Commercial Distribution
Brand Name	NeoLumax CLIA Analyzer
Version Model Number	IN010
Catalog Number	IN010
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	00816870020006 [Primary]

JJQ	COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE

Steralize Prior To Use	false
Device Is Sterile	false

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