Nova Primary 63457

GUDID 10385480634578

Glucose analyser IVD, laboratory, automated/semi-automated

Primary Device ID	10385480634578
NIH Device Record Key	fc2d4904-18ec-4a24-9474-fc20168c35fc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Nova Primary
Version Model Number	Nova Primary Analyzer
Catalog Number	63457
Company DUNS	070617139
Company Name	NOVA BIOMEDICAL 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	true
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	00385480634571 [Primary]
GS1	10385480634578 [Package] Contains: 00385480634571 Package: [1 Units] In Commercial Distribution

CGA	GLUCOSE OXIDASE, GLUCOSE

Steralize Prior To Use	false
Device Is Sterile	false

10385480634578	Nova Primary Glucose Analyzer
00385480631624	Nova Primary Calibrator Cartridge 450 Sample
00385480632317	Nova Primary Glucose Sensor
00385480631679	Nova Primary Calibrator Cartridge 150 Sample
00385480632300	Nova Primary Glucose Membrane
00385480631662	Nova Primary Linearity Level 2
00385480631655	Nova Primary Linearity Level 1
00385480631648	Nova Primary Ampuled Control 1, 2