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FUJIFILM IRVINE SCIENTIFIC, INC.

Last updated May 24, 2026

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 1 of 3

Device	Model / Reference	Registries	Class	Status
ISolate®	99264-12X6mL	FDA UDI	Class II	Active
Multipurpose Handling Medium®-Complete (MHM®-C)	90166-100mL	FDA UDI	Class II	Active
Modified Sperm Washing Medium	9984-12X12mL	FDA UDI	Class II	Unknown
ISolate®	99264-2x100mL	FDA UDI	Class II	Active
Blastocyst Thaw Media Kit	90110-6X10ML	FDA UDI	Class II	Unknown
Chang Amnio	99473-500ML	FDA UDI	Class I	Active
Vit Kit® - Thaw	90137-SO	FDA UDI	Class II	Active
Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin	90128-100mL	FDA UDI	Class II	Active
Chang Medium B	C100-90ML	FDA UDI	Class I	Active
cryo-GO Vitrification Device	70312-R	FDA UDI	Class II	Active
Vit Kit® - Thaw	90137-DSOC	FDA UDI	Class II	Active
Human Serum Albumin Solution	9988-100mL	FDA UDI	Class II	Unknown
Dextran Serum Supplement	9301-100mL	FDA UDI	Class II	Unknown
ISolate® Stock Solution	99275-12x6ML	FDA UDI	Class II	Active
Vit Kit® - Freeze	90133-SO	FDA UDI	Class II	Active
Polyvinylpyrrolidone (PVP) - Lyophilized	99219-10x1mL	FDA UDI	Class II	Unknown
Modified Sperm Washing Medium	9984-100ML	FDA UDI	Class II	Unknown
cryo-GO Vitrification Device	70310-G	FDA UDI	Class II	Active
Thawing NX - TS	90179-2X20ML	FDA UDI	Class II	Active
Chang Medium MF with Gentamicin	91005-100ML	FDA UDI	Class I	Active
Embryo Freeze Media	90116-6X10ML	FDA UDI	Class II	Unknown
Arctic Sperm Cryopreservation Medium	90170-3x5mL-SK	FDA UDI	Class II	Active
ISolate® Stock Solution	99275-100ML	FDA UDI	Class II	Active
Multipurpose Handling Medium®-Complete (MHM®-C)	90166-500mL	FDA UDI	Class II	Active
Water for Assisted Reproductive Technologies (A.R.T.) Use	9307-1L	FDA UDI	Class II	Active
Chang Medium C	T101-059	FDA UDI	Class I	Active
Chang Medium MF with Gentamicin	91005-500ML	FDA UDI	Class I	Active
cryo-GO Vitrification Device	70311-P	FDA UDI	Class I	Active
Vit Kit® - Thaw	90137-JX	FDA UDI	Class II	Active
Sperm Washing Medium	9983-500mL	FDA UDI	Class II	Active
Sperm Maintenance Medium	99176-12X5ML	FDA UDI	Class II	Unknown
Colcemid Solution	9311-12x10ml	FDA UDI	Class I	Active
MultiBlast Medium®	90139-60mL	FDA UDI	Class II	Unknown
Vit Kit - Freeze NX	90188	FDA UDI	Class II	Active
Serum Substitute Supplement™	99193-100ML	FDA UDI	Class II	Active
Complete Early Cleavage Medium with DSS	90142-2X20mL	FDA UDI	Class II	Unknown
Continuous Single Culture®–NX (CSCM–NX)	90167-20ML	FDA UDI	Class II	Active
Chang Medium in SITU	T104-500ML	FDA UDI	Class I	Active
cryo-GO Vitrification Device	70308-Y	FDA UDI	Class II	Active
7% PVP Solution with HSA	90121-5X0.5mL	FDA UDI	Class II	Active
Human Serum Albumin Solution	9988-12X5mL	FDA UDI	Class II	Active
Chang Medium BMC with Gentamicin	91004-100ML	FDA UDI	Class I	Active
Heavy Oil for Embryo Culture	90189-100mL	FDA UDI	Class II	Active
Multipurpose Handling Medium®-Complete (MHM®-C)	90166-12x12mL	FDA UDI	Class II	Active
ISolate® Concentrate	99306-1L	FDA UDI	Class II	Active
Early Cleavage Medium	90138-60mL	FDA UDI	Class II	Unknown
Colcemid Solution	9311-10ml	FDA UDI	Class I	Active
Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells	99419-500mL	FDA UDI	N/A	Unknown
Complete HTF Medium with SSS™	9922-2X20mL	FDA UDI	Class II	Unknown
Chang Marrow Bone Marrow Culture Medium with Gentamicin	91031-100mL	FDA UDI	Class I	Active

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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.

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