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) (9) Kit, Culture, Chromosome (KIQ) (1)

Premarket Exempt

No Yes

Clear

Continuous Single Culture®–NX (CSCM–NX) - 00857515006221 Catalog Number : 90167

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

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Continuous Single Culture®–NX Complete - 00857515006238 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

Sperm Washing Medium - 00857515006245 Catalog Number : 9983

Device Description : Sperm Washing Medium- Made to order configuration

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Arctic Sperm Cryopreservation Medium - 00857515006252 Catalog Number : 90170

Device Description : Arctic Sperm Cryopreservation Medium

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 12

ISolate® Stock Solution - 00857515006269 Catalog Number : 99275

Device Description : ISolate® Stock SolutionCustom packaging configuration. Only distributed in Japan.

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 12

Multipurpose Handling Medium®-Complete (MHM®-C) - 00857515006276 Catalog Number : 90166

Device Description : Multipurpose Handling Medium®-Complete (MHM®-C) with Gentamicin

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 12

Colcemid Solution - 00857515006306 Catalog Number : 9311

Device Description : Colcemid Solution

Device Class : 1

Duns Number: 057475246

Premarket Exempt : Yes

Product Code : KIQ

Prescription Use : No

Device Count : 12

VIT KIT - Warm NX - 00857515006313 Catalog Number : 90183

Device Description : VIT KIT - Warm NX

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Vit Kit - Freeze NX - 00857515006320 Catalog Number : 90188

Device Description : Vit Kit - Freeze NX

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Heavy Oil for Embryo Culture - 00857515006337 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

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