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Advanced Instruments, LLC

United States·US-MF-000027205

Last updated September 17, 2026

About

Nova Biomedical provides innovative, high-quality analytical instruments and services for bioprocessing, clinical and veterinary industries.

From the manufacturer's own website. Source

Information

Country: United States
Address: 2, Technology Way, Norwood, United States
Website: www.novabiomedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 781-320-9000
PRRC Contact: Autumn Collasius
EUDAMED SRN: US-MF-000027205
FDA FEI Number: 1217058
DUNS Number: —

Catalogue (92)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Advanced Instruments GloCyte® Test Cartridge & Tray - 25 Cartridges	111096	FDA UDI	Class II	Active
Advanced Instruments GloCyte® Instrument Assembly	111000	FDA UDI	Class II	Active
Advanced Instruments BR2 Hydrochloric Acid	B2A102Y	FDA UDI	Class II	Active
Advanced Instruments GloCyte® Count Template Cartridge	111153	FDA UDI	Class II	Active
Advanced Instruments GloCyte® Automated Cell Counter System	GloCyte	FDA UDI	Class II	Active
Advanced Instruments GloCyte® Vacuum Preparation Station Assembly	111076	FDA UDI	Class II	Active
Advanced Instruments Swab Cleaners	202850	FDA UDI	Class I	Active
Advanced Instruments Model 3250 Single-Sample Osmometer	3250	FDA UDI	Class I	Active
Advanced Instruments 1000 mOsm Calibration Standard - 2mL Ampule - Pkg 10	3MA100	FDA UDI	Class I	Active
Advanced Instruments Osmo1® Single-Sample Micro-Osmometer	Osmo1	FDA UDI	Class I	Active
Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 10	3LA051	FDA UDI	Class I	Active
Advanced Instruments BR2 20 mg/dL Bilirubin Equivalent Solution	B2A101H	FDA UDI	Class II	Active
Advanced Instruments Standard Anoxomat Jar, Medium	AJ9025	FDA UDI	Class I	Active
Advanced Instruments BR2 Sulfanilic Acid	B2A102S	FDA UDI	Class II	Active
Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes	B2A102	FDA UDI	Class II	Active
Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 10	3LA201	FDA UDI	Class I	Active
Advanced Instruments 900 mOsm Calibration Standard - 110 mL Bottle	3LA090	FDA UDI	Class I	Active
Advanced Instruments BR2 5mg/dL Bilirubin Equivalent Solution	B2A101L	FDA UDI	Class II	Active
Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10	3MA200	FDA UDI	Class I	Active
A20 Advanced Automated Osmometer	A2O	FDA UDI	Class I	Active
Advanced Instruments 400 mOsm Calibration Standard - 2mL Ampule - Pkg 10	3MA040	FDA UDI	Class I	Active
Advanced Instruments BR2 Sodium Nitrite	B2A102N	FDA UDI	Class II	Active
Fiske 210 Single-Sample Micro-Osmometer	210	FDA UDI	Class I	Active
Advanced Instruments RBC Reagent Filtration Kit	111014	FDA UDI	Class II	Active
Advanced Instruments GloCyte® Low Level Control Vial (Single)	111111	FDA UDI	Class II	Active
Advanced Instruments BR2 Bilirubin Stat-Analyzer	BR2	FDA UDI	Class II	Active
Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V)	Anoxomat III (100V - 120V)	FDA UDI	Class I	Active
Advanced Instruments BR2 Sample Diluent	B2A101D	FDA UDI	Class II	Active
Advanced Instruments BR2 Disposable Cuvettes	B2A800	FDA UDI	Class II	Active
Advanced Instruments GloCyte® Controls Kit	111013	FDA UDI	Class II	Active
Advanced Instruments Bin Setting Fluid – 10 mL	3LA009	FDA UDI	Class I	Active
Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 10	3MA005	FDA UDI	Class I	Active
Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8	3LA085	FDA UDI	Class I	Active
Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer	OsmoPRO	FDA UDI	Class I	Active
Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 10	3LA029	FDA UDI	Class I	Active
Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit	111280	FDA UDI	Class II	Active
Advanced Instruments 200 mOsm Calibration Standard - 2mL Ampule - Pkg 10	3MA020	FDA UDI	Class I	Active
Advanced Instruments OsmoTECH PRO Probe Wiper Rings	222840	FDA UDI	Class I	Active
Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and Cuvettes	B2A101	FDA UDI	Class II	Active
Advanced Instruments Heat Transfer Fluid	3DA811	FDA UDI	Class I	Active
Advanced Instruments A2O Osmometer Probe Wiper Rings	200221	FDA UDI	Class I	Active
Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10	3LA028	FDA UDI	Class I	Active
Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume	806053	FDA UDI	Class II	Active
Advanced Instruments 3000 mOsm Calibration Standard - 5mL Ampule - Pkg 10	3LA301	FDA UDI	Class I	Active
Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume	806054	FDA UDI	Class II	Active
Advanced Instruments Palladox Disposable Satchet	AN3146	FDA UDI	Class I	Active
Advanced Instruments 500 mOsm Calibration Standard - 110 mL Bottle	3LA050	FDA UDI	Class I	Active
Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 10	3MA400	FDA UDI	Class I	Active
Advanced Instruments 2020 Osmometer Probe Wiper Rings	202840	FDA UDI	Class I	Active
Advanced Instruments 1500 mOsm Calibration Standard - 110 mL Bottle	3LA150	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Wmde B.v. NL

Importers

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 11, 2024	Z-1696-2024	—	open, classified	System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
Feb 7, 2018	Z-0640-2019	—	terminated	RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.