Immunoglobulins G

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K873870 ↗

FDA Product Code

DEW

FDA applicant

Unipath , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K911566 Active Cleared 6 May 1991

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• Turbox Fibrinogen

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  FDA 510(k) K884179 Active Cleared 20 Dec 1988

• Clearblue Easy Earliest Results Pregnancy Test

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• Cell-Dyn 3000A Multi-Parameter Auto Hema Analzyer

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• E.P.T. Certainty Pregnancy Test

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See all devices from Unipath, Ltd. →

• What is Immunoglobulins G primarily used for in clinical or research settings?

  Immunoglobulins G is a purified gamma globulin derived from human plasma, designed to provide passive immunity or assist in laboratory testing by binding to specific antigens. It is classified as an antigen, antiserum, or control and is used in immunology for diagnostic or therapeutic purposes, such as supporting serological assays or immune response evaluations.

• Is Immunoglobulins G intended for single-use or repeated use, and how should it be stored?

  Immunoglobulins G is supplied as a sterile, liquid formulation and is intended for single-use only in clinical or research settings. Storage requirements and dosage instructions are detailed in the accompanying documentation, which must be followed to maintain efficacy and sterility, adhering to standard immunology protocols.

• What regulatory pathway was followed for Immunoglobulins G, and what class does it fall under?

  Immunoglobulins G was cleared through the FDA’s 510(k) pathway (traditional review) under the Immunology (IM) Advisory Committee, with a decision of *Substantially Equivalent*. It is classified as a Class II device under the product code DEW, indicating moderate regulatory oversight for its intended diagnostic or therapeutic use in immunology.

• Are there multiple lot numbers or batch identifiers associated with Immunoglobulins G, and what does this imply?

  Yes, Immunoglobulins G is associated with multiple FEI numbers (e.g., 3008237827, 3005333358, etc.) and registration numbers, indicating it may be produced in different batches or formulations. These identifiers help track specific lots for quality control, expiration, and traceability in clinical or research use, ensuring compliance with regulatory requirements.