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 And Components, Synthetic Cell And Tissue Culture (KIT) (5) Media, Reproductive (MQL) (5) Kit, Culture, Chromosome (KIQ) (3)

Premarket Exempt

No Yes

Clear

Chang Medium B - 00857515006108 Catalog Number : C101

Device Description : CHANG Basal-450ml

Device Class : 1

Duns Number: 057475246

Premarket Exempt : Yes

Product Code : KIQ, KIT

Prescription Use : No

Device Count : 1

Chang C 14ML Frozen Supplement - 00857515006115 Catalog Number : C106

Device Description : Chang C 14ML Frozen Supplement

Device Class : 1

Duns Number: 057475246

Premarket Exempt : Yes

Product Code : KIT

Prescription Use : No

Device Count : 1

Chang C 70ML Frozen Supplement - 00857515006122 Catalog Number : C108

Device Description : Chang C 70ML Frozen Supplement

Device Class : 1

Duns Number: 057475246

Premarket Exempt : Yes

Product Code : KIT

Prescription Use : No

Device Count : 1

Chang Medium BMC with Gentamicin - 00857515006153 Catalog Number : 91004

Device Description : Chang Medium BMC with Gentamicin

Device Class : 1

Duns Number: 057475246

Premarket Exempt : Yes

Product Code : KIQ, KIT

Prescription Use : No

Device Count : 1

Chang Medium MF with Gentamicin - 00857515006160 Catalog Number : 91005

Device Class : 1

Duns Number: 057475246

Premarket Exempt : Yes

Product Code : KIT, KIQ

Prescription Use : No

Device Count : 1

Vit Kit® - Freeze - 00857515006177 Catalog Number : 90133-DSOC

Device Description : Vit Kit - FreezeCustom package configuration

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Vit Kit® - Thaw - 00857515006184 Catalog Number : 90137-DSOC

Device Description : Vit Kit - ThawCustom package configuration

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Vit Kit® - Thaw - 00857515006191 Catalog Number : 90137-JX

Device Description : Vitrification Thaw Kit for EmbryosCustom for JX

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sperm Washing Medium - 00857515006207 Catalog Number : 9983

Device Description : Sperm Washing Medium. Custom packaging size.

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Continuous Single Culture®–NX (CSCM–NX) - 00857515006214 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

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