Is this your brand? Sign in to claim ownership.

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 2 of 2

Device	Model / Reference	Registries	Class	Status
Advanced Instruments 0 mOsm Calibration Standard - 2mL Ampule - Pkg 10	3MA000	FDA UDI	Class I	Active
Advanced Instruments Ergonomic Culture Jar, Small	AJ9049	FDA UDI	Class I	Active
Advanced Instruments GloCyte® High Level Control Vial (Single)	111113	FDA UDI	Class II	Active
Advanced Instruments 900 mOsm Calibration Standard - 5mL Ampule - Pkg 10	3LA091	FDA UDI	Class I	Active
Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit	111011	FDA UDI	Class II	Active
Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 10	3LA011	FDA UDI	Class I	Active
Advanced Instruments Ergonomic Culture Jar, Large	AJ9050	FDA UDI	Class I	Active
Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent Kit	111012	FDA UDI	Class II	Active
Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays	111010	FDA UDI	Class II	Active
Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 10	3MA003	FDA UDI	Class I	Active
Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9	3MA028	FDA UDI	Class I	Active
Advanced Instruments Standard Anoxomat Jar, Large	AJ9028	FDA UDI	Class I	Active
Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 10	3LA151	FDA UDI	Class I	Active
Advanced Instruments 100 mOsm Calibration Standard - 110 mL Bottle	3LA010	FDA UDI	Class I	Active
Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 10	3MA029	FDA UDI	Class I	Active
Advanced Instruments A2O System Fluid	200222	FDA UDI	Class I	Active
Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 10	3MA085	FDA UDI	Class I	Active
Patient Monitor	K120631	FDA 510(k)	Class II	Active
Osmometer Model 110	K873642	FDA 510(k)	Class I	Active
Ceregrotrac	K842784	FDA 510(k)	Class II	Active
Vital Signs Monitor	K112465	FDA 510(k)	Class II	Active
Osmometer Model 2400	K911092	FDA 510(k)	Class I	Active
Model 3d3 Osmometer	K925970	FDA 510(k)	Class I	Active
Electronic Metal Locator Model Md-1	K863516	FDA 510(k)	N/A	Active
Osmometer Model 3w11	K790611	FDA 510(k)	Class I	Active
Bl Bilirubinometer	K790608	FDA 510(k)	Class II	Active
Video Print	K840385	FDA 510(k)	Class II	Active
Glocyte Automated Cell Counter System	K152776	FDA 510(k)	Class II	Active
Intermittent Compression System Model 5000	K930526	FDA 510(k)	Class II	Active
Micro-Sample Osmometer 3m0	K832783	FDA 510(k)	Class I	Active
Bilirubinometer	K811840	FDA 510(k)	Class I	Active
The Advanced Osmometer (3900)	K965036	FDA 510(k)	Class I	Active
Advanced Micro-Osmometer Model 3300	K962056	FDA 510(k)	Class I	Active
Sample Tube – Plastic 0.2ml, 1x500	3LA825	EUDAMEDFDA UDI	Class A	Active
Sample Tubes & Probe Wipes, 1x250	110825	EUDAMEDFDA UDI	Class A	Active
20 Microliter Pipette	240820	EUDAMEDFDA UDI	Class A	Active
Disposable Sample Tubes	202825	EUDAMEDFDA UDI	Class A	Active
Micro-Sample Test Kit	133800	EUDAMEDFDA UDI	Class A	Active
12mm X 75mm Primary Sample Tubs, Box Of 250	200220	EUDAMEDFDA UDI	Class A	Active
A2O Sample Tubes, Box Of 500	200223	EUDAMEDFDA UDI	Class A	Active
Pipette Tips with Graduations 5-200 μL	800097	EUDAMEDFDA UDI	Class A	Active
Ease-Eject Sampler	3M0825	EUDAMEDFDA UDI	Class A	Active

Related Companies

Authorised Representatives

Wmde B.v. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.