SSS-NX (Serum Substitute Supplement-NX)

FDA UDI

Class II (US FDA UDI)

by Fujifilm Irvine Scientific, Inc.

Identity

Trade Name: SSS-NX (Serum Substitute Supplement-NX) FDA UDI
Generic Name: IVF medium FDA UDI
Device Name: SSS-NX (Serum Substitute Supplement-NX) consists of human serum albumin and human serum globulins in saline solution and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for culture medium. FDA UDI
Model / Reference: 90194 100 mL FDA UDI
Description: SSS-NX (Serum Substitute Supplement-NX) consists of human serum albumin and human serum globulins in saline solution and is intended for use in assisted reproductive procedures which include gamete and embryo manipulation and culture. These procedures include the use of SSS-NX as a supplement for culture medium. FDA UDI

Identifiers

Catalog Number: 90194 FDA UDI
Primary DI / UDI-DI: 00857515006634 FDA UDI
FDA Product Code: MQL FDA UDI
GMDN Term: IVF medium FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.6180 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: IVF medium

SSS-NX (Serum Substitute Supplement-NX) by Fujifilm Irvine Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fujifilm Irvine Scientific, Inc.

Sources (1)

FDA UDI 9dc5cd1e-ef48-47c4-898f-6ef9ace0f616 36 fields · synced May 30, 2026