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

Embryo Thaw Media Kit - 00893727002187 Catalog Number : 90124

Device Description : Embryo Thaw Media

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Modified HTF Medium-HEPES with Gentamicin - 00893727002194 Catalog Number : 90126

Device Description : Modified HTF Medium-HEPES

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin - 00893727002200 Catalog Number : 90128

Device Description : Freezing Medium With Gentamicin

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Freezing Medium - TEST Yolk Buffer (TYB) with Glycerol and Gentamicin - 00893727002217 Catalog Number : 90128

Device Description : Freezing Medium With Gentamicin

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 20

Early Cleavage Medium - 00893727002248 Catalog Number : 90138

Device Description : Early Cleavage Medium (ECM) with Gentamicin

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

MultiBlast Medium® - 00893727002255 Catalog Number : 90139

Device Description : MultiBlast Medium with Gentamicin

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Complete Early Cleavage Medium® (ECM®) with SSS - 00893727002262 Catalog Number : 90140

Device Description : Complete Early Cleavage With SSS

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 2

Complete MultiBlast Medium® with SSS - 00893727002279 Catalog Number : 90141

Device Description : Complete MultiBlast With SSS

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 2

Complete Early Cleavage Medium with DSS - 00893727002286 Catalog Number : 90142

Device Description : Complete Early Cleavage (ECM) With DSS

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 2

Complete MultiBlast Medium With DSS - 00893727002293 Catalog Number : 90143

Device Description : Complete MultiBlast With DSS

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 2

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