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) (10)

Premarket Exempt

No Yes

Clear

Heavy Oil for Embryo Culture - 00857515006344 Catalog Number : 90189

Device Description : Heavy Oil for Embryo Culture

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb - 00857515006412 Catalog Number : 90165

Device Description : Continuous Single Culture® Complete with HSA

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Continuous Single Culture®–NX Complete - 00857515006429 Catalog Number : 90168

Device Description : Continuous Single Culture®–NX Complete (CSCM–NXC)

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Arctic Sperm Cryopreservation Medium - 00857515006436 Catalog Number : 90170

Device Description : Arctic Sperm Cryopreservation MediumSample Kit- NOT FOR SALE

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 3

Oil for Embryo Culture - 00893727002002 Catalog Number : 9305

Device Description : Oil for Embryo Culture

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

PBS 1X - Dulbecco's Phosphate Buffered Saline Solution - 00893727002019 Catalog Number : 9235

Device Description : PBS 1X Dulbecco's

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Dextran Serum Supplement - 00893727002026 Catalog Number : 9301

Device Description : Dextran Serum Supplement

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Dextran Serum Supplement - 00893727002033 Catalog Number : 9301

Device Description : Dextran Serum Supplement

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 12

Complete HTF Medium with SSS™ - 00893727002057 Catalog Number : 9922

Device Description : Complete HTF Medium With SSS

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 2

Complete P-1® Medium with SSS™ - 00893727002064 Catalog Number : 9926

Device Description : Complete P-1 Medium With SSS

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 2

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