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Northeast Laboratory Services, Inc.

Last updated May 23, 2026

What Northeast Laboratory Services, Inc. makes

Northeast Laboratory Services, Inc. manufactures in vitro diagnostic (IVD) microbiological culture media, including differential and selective agar and broth formulations, basic nutrient agar and broth, enriched agar, isotonic saline reagents, distilled sterile water suspensions, and the Voges-Proskauer (VP) microbial reagent. These products are designed for use in clinical microbiology laboratories to support bacterial and microbial identification and testing.

The company’s products are classified under FDA’s In Vitro Diagnostic Device regulations, with devices falling into both Class I and Class II categories. These items are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory compliance within the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Northeast Laboratory Services, Inc. manufacture?

Northeast Laboratory Services, Inc. specializes in in vitro diagnostic (IVD) microbiological culture media. Their products include differential and selective agar and broth formulations, basic nutrient agar and broth, enriched agar, isotonic saline reagents, distilled sterile water suspensions, and the Voges-Proskauer (VP) microbial reagent. These are designed for clinical microbiology labs to aid in bacterial and microbial identification and testing.

Where is Northeast Laboratory Services, Inc. based?

Northeast Laboratory Services, Inc. is based in the United States. The company’s products are regulated under FDA’s In Vitro Diagnostic Device (IVD) regulations, which aligns with the U.S. market.

Which regulatory registries list devices manufactured by Northeast Laboratory Services, Inc.?

Devices manufactured by Northeast Laboratory Services, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for their IVD products within the U.S. regulatory framework.

How are the devices produced by Northeast Laboratory Services, Inc. classified under FDA regulations?

The devices produced by Northeast Laboratory Services, Inc. fall under FDA’s In Vitro Diagnostic Device regulations and are classified into both Class I and Class II categories. Classification depends on factors like the intended use, risk level, and potential impact on patient health, with Class II devices typically requiring additional controls due to moderate risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 071749709

Catalogue (137)

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Device	Model / Reference	Registries	Class	Status
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Unknown
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active
Northeast Laboratory Services	1	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Notified Bodies

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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.

Northeast Laboratory Services, Inc. has two recall records, both initiated on December 21, 2015. Both records are marked as terminated. The reasons provided state that the products were marketed without a required 510(k) clearance.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Dec 21, 2015	Z-1314-2016	—	terminated	Product marketed without a 510 (k)
Dec 21, 2015	Z-1313-2016	—	terminated	Product marketed without a 510 (k)