FUJIFILM IRVINE SCIENTIFIC, INC.

Address:2511 DAIMLER ST,Santa Ana,CA,92705,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Media, Reproductive (MQL) (6) Media And Components, Synthetic Cell And Tissue Culture (KIT) (3) System,Water,Reproduction,Assisted,And Purification (MTW) (1)

Premarket Exempt

No Yes

Clear

ISolate® - 00857515006009 Catalog Number : 99264

Device Description : ISolate

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 2

ISolate® Stock Solution - 00857515006016 Catalog Number : 99275

Device Description : ISolate® Stock Solution

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

ISolate® Concentrate - 00857515006023 Catalog Number : 99306

Device Description : ISolateCustom package configuration

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

CHANG Medium® D with Antibiotics - 00857515006030 Catalog Number : 99404

Device Description : CHANG Medium® D with Gentamicin

Device Class : 1

Duns Number: 057475246

Premarket Exempt : Yes

Product Code : KIT

Prescription Use : No

Device Count : 1

Chang Medium® C with Gentamicin For Human Amniotic Fluid Cells - 00857515006047 Catalog Number : 99418

Device Description : Chang Medium C with Gentamicin99418-90mL is longer being sold on its own. It can Chang Medium C with Gentamicin99418-90mL is longer being sold on its own. It can now only be purchased as part of the 99419-100ml kit.

Device Class : 1

Duns Number: 057475246

Premarket Exempt : Yes

Product Code : KIT

Prescription Use : No

Device Count : 1

Chang Medium® C with Gentamicin - 00857515006054 Catalog Number : 99418

Device Description : Chang Medium C with Gentamicin

Device Class : 1

Duns Number: 057475246

Premarket Exempt : Yes

Product Code : KIT

Prescription Use : No

Device Count : 1

Sperm Maintenance Medium - 00857515006061 Catalog Number : 99176

Device Description : Sperm Maintenance Medium

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 12

Water for Assisted Reproductive Technologies (A.R.T.) Use - 00857515006078 Catalog Number : 9307

Device Description : Water for Assisted Reproductive Technologies (A.R.T.) Use Custom package

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MTW

Prescription Use : Yes

Device Count : 1

Vit Kit® - Freeze - 00857515006085 Catalog Number : 90133-DSO

Device Description : Vit Kit - Freeze

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Vit Kit® - Thaw - 00857515006092 Catalog Number : 90137-DSO

Device Description : Vit Kit - Thaw

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

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