Is this your brand? Sign in to claim ownership.

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 2 of 3

Device	Model / Reference	Registries	Class	Status
Chang Marrow Bone Marrow Culture Medium with Gentamicin	91031-500mL	FDA UDI	Class I	Active
Chang Medium C	T101-019	FDA UDI	Class I	Active
Continuous Single Culture®	90164-60mL	FDA UDI	Class II	Active
Water for Assisted Reproductive Technologies (A.R.T.) Use	9307-50ML	FDA UDI	Class II	Active
CHANG Medium C Lyophilized	99419-100mL	FDA UDI	Class I	Active
Chang Medium D	T105-500mL	FDA UDI	Class I	Active
Multipurpose Handling Medium® (MHM®)	90163-500mL	FDA UDI	Class II	Active
Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin	90128-20X5mL	FDA UDI	Class II	Active
SSS-NX (Serum Substitute Supplement-NX)	90194 12x10 mL	FDA UDI	Class II	Active
Chang Medium in SITU	T104-100ML	FDA UDI	Class I	Active
Complete MultiBlast Medium With DSS	90143-2X20mL	FDA UDI	Class II	Unknown
Chang Medium® C with Gentamicin	99418-450mL	FDA UDI	Class I	Unknown
Complete Early Cleavage Medium® (ECM®) with SSS	90140-2X20mL	FDA UDI	Class II	Unknown
cryo-GO Vitrification Device	70313-Y	FDA UDI	Class II	Active
Heavy Oil for Embryo Culture	90189-500mL	FDA UDI	Class II	Active
Vit Kit® - Thaw	90137-DSO	FDA UDI	Class II	Active
Modified Ham's F-10 Basal Medium - HEPES	99168-100ML	FDA UDI	Class II	Unknown
Chang Medium D	T105-100mL	FDA UDI	Class I	Active
P-1® Medium with Gentamicin	99242-100mL	FDA UDI	Class II	Active
PBS 1X - Dulbecco's Phosphate Buffered Saline Solution	9235-500mL	FDA UDI	Class II	Active
ISolate® Stock Solution	99275-500ML	FDA UDI	Class II	Unknown
Serum Substitute Supplement™	99193-12X12mL	FDA UDI	Class II	Active
Chang Medium BMC with Gentamicin	91004-500ML	FDA UDI	Class I	Active
cryo-GO Vitrification Device	70314-B	FDA UDI	Class II	Active
Modified HTF Medium-HEPES with Gentamicin	90126-100mL	FDA UDI	Class II	Active
Chang C 70ML Frozen Supplement	C108-70ML	FDA UDI	Class I	Active
Modified Ham's F-10 with Albumin	99109-12X12ML	FDA UDI	Class II	Unknown
Hyaluronidase Solution	90101-5X1mL	FDA UDI	Class II	Active
Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells	99418-90mL	FDA UDI	Class I	Unknown
Sperm Washing Medium	9983-12X12mL	FDA UDI	Class II	Active
Continuous Single Culture®–NX Complete	90168-60mL	FDA UDI	Class II	Active
Vit Kit® - Freeze	90133-DSO	FDA UDI	Class II	Active
Chang C 14ML Frozen Supplement	C106-14ML	FDA UDI	Class I	Active
SSS-NX (Serum Substitute Supplement-NX)	90194 100 mL	FDA UDI	Class II	Active
CHANG Medium® D with Antibiotics	99404-100mL	FDA UDI	Class I	Active
Oil for Embryo Culture	9305-100mL	FDA UDI	Class II	Active
Embryo Biopsy Medium	90103-2X20mL	FDA UDI	Class II	Unknown
Tyrode's Solution - Acidified	99252-12X5ML	FDA UDI	Class II	Unknown
Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin	90129-20x5mL	FDA UDI	Class II	Active
ISolate®	99264-2x50mL	FDA UDI	Class II	Active
cryo-GO Vitrification Device	70309-B	FDA UDI	Class II	Active
Chang Amnio	99473-100ML	FDA UDI	Class I	Active
VIT KIT - Warm NX	90183	FDA UDI	Class II	Active
10% PVP Solution with HSA	90123-5X0.5mL	FDA UDI	Class II	Active
Embryo Thaw Media Kit	90124-6X10mL	FDA UDI	Class II	Unknown
cryo-GO Vitrification Device	70316-P	FDA UDI	Class II	Active
CryoTip®	40709-Pack	FDA UDI	Class II	Active
CHANG Medium® D with Antibiotics	99404-500mL	FDA UDI	Class I	Unknown
Modified Ham's F-10 with Albumin	99109-100ML	FDA UDI	Class II	Unknown
cryo-GO Vitrification Device	70315-G	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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