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) (8) Cap, Cervical (HDR) (1) System,Water,Reproduction,Assisted,And Purification (MTW) (1)

Premarket Exempt

No Yes

Clear

HTF Medium with Gentamicin - 00893727002804 Catalog Number : 90125

Device Description : HTF Medium with Gentamicin

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Vit Kit® - Freeze - 00893727002811 Catalog Number : 90133-SO

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 - 00893727002828 Catalog Number : 90137-SO

Device Description : Vit Kit - Thaw

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Modified Ham's F-10 Basal Medium - HEPES - 00893727002835 Catalog Number : 99168

Device Description : Modified Ham's F-10 Basal Medium - HEPES

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

ISolate® Stock Solution - 00893727002859 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

Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin - 00893727002866 Catalog Number : 90129

Device Description : Refrigeration Test Yolk Buffer with Gentamicin

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : HDR

Prescription Use : Yes

Device Count : 20

Water for Assisted Reproductive Technologies (A.R.T.) Use - 00893727002880 Catalog Number : 9307

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

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MTW

Prescription Use : Yes

Device Count : 1

Modified Sperm Washing Medium - 00893727002897 Catalog Number : 9984

Device Description : Modified Sperm Washing Medium

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Human Serum Albumin Solution - 00893727002903 Catalog Number : 9988

Device Description : Human Albumin

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

HTF Medium with Gentamicin - 00893727002910 Catalog Number : 90125

Device Description : HTF Medium with Gentamicin

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

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