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FUJIFILM IRVINE SCIENTIFIC, INC.

Last updated May 24, 2026

What FUJIFILM IRVINE SCIENTIFIC, INC. makes

The company produces media and reagents for in vitro fertilization (IVF), including handling and storage solutions like ISolate® and Multipurpose Handling Medium®-Complete, as well as specialized IVD reagents for karyotype suspension testing of amniotic fluid and chorionic villus samples. It also manufactures vitrification carriers and cryotubes for assisted reproduction, alongside thawing and freezing kits for embryo preservation, such as Vit Kit® and Freezing Medium with glycerol. Microtools for assisted reproduction procedures are included in the portfolio.

The portfolio includes Class I and Class II medical devices, regulated under FDA pathways such as 510(k) and UDI compliance. These products are listed in the US regulatory system, with devices authorised for IVF media, diagnostic reagents, and cryopreservation accessories.

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

Information

Country: US
Address: —
Website: irvinesci.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8004375706
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 057475246

Catalogue (126)

Page 3 of 3

Device	Model / Reference	Registries	Class	Status
Vit Kit® - Freeze	90133-DSOC	FDA UDI	Class II	Active
Sperm Washing Medium	9983-1L	FDA UDI	Class II	Unknown
Chang Medium B	C101-450mL	FDA UDI	Class I	Active
HTF Medium with Gentamicin	90125-500mL	FDA UDI	Class II	Active
cryo-GO Vitrification Device	70307-R	FDA UDI	Class II	Active
Modified Ham's F-10 Basal Medium	99175-100ML	FDA UDI	Class II	Active
Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb	90165-60mL	FDA UDI	Class II	Active
Dextran Serum Supplement	9301-12X12mL	FDA UDI	Class II	Unknown
Complete MultiBlast Medium® with SSS	90141-2X20mL	FDA UDI	Class II	Unknown
Continuous Single Culture®–NX (CSCM–NX)	90167-60ML	FDA UDI	Class II	Active
Arctic Sperm Cryopreservation Medium	90170-12x5mL	FDA UDI	Class II	Active
Continuous Single Culture®–NX Complete	90168-2x20mL	FDA UDI	Class II	Active
Modified HTF Medium-HEPES with Gentamicin	90126-500mL	FDA UDI	Class II	Active
Complete P-1® Medium with SSS™	9926-2X20mL	FDA UDI	Class II	Unknown
Multipurpose Handling Medium® (MHM®)	90163-100mL	FDA UDI	Class II	Active
ISolate® Concentrate	99306-100ml	FDA UDI	Class II	Active
HTF Medium with Gentamicin	90125-100mL	FDA UDI	Class II	Active
Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb	90165-2x20mL	FDA UDI	Class II	Active
Oil for Embryo Culture	9305-500mL	FDA UDI	Class II	Active
Sperm Maintenance Medium	99176-100ml	FDA UDI	Class II	Unknown
Sperm Washing Medium	9983-100mL	FDA UDI	Class II	Active
PRIME-XV FreezIS DMSO-Free MD	K231804	FDA 510(k)	Class II	Active
Fast Warm - NX	K250445	FDA 510(k)	Class II	Active
cryo-GO Vitrification Device	K241341	FDA 510(k)	Class II	Active
SSS-NX (Serum Substitute Supplement-NX)	K233764	FDA 510(k)	Class II	Active
Vit Kit- Freeze NX and Vit Kit- Warm NX	K190152	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Authorities

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FDA Recalls (4)

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

Fujifilm Irvine Scientific, Inc. has four recall records initiated between September 8, 2021, and November 2, 2023, with statuses listed as either open or classified. The reasons provided include the detection of oil toxicity in Oil for Embryo Culture products, discrepancies in the lower layer component of a sperm separation kit (mismatched lot numbers and expiration dates), and incorrect expiration date labeling on a kit component.

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
Nov 2, 2023	Z-0998-2024	—	open, classified	The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).
Jan 16, 2023	Z-1314-2023	—	open, classified	Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.
Sep 8, 2021	Z-0248-2022	—	open, classified	Due to a component in kit being labeled with the incorrect Expiration Date
Sep 8, 2021	Z-0249-2022	—	open, classified	Due to a component in kit being labeled with the incorrect Expiration Date