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) Microtools, Assisted Reproduction (Pipettes) (MQH) (1)

Premarket Exempt

No Yes

Clear

Sperm Washing Medium - 00893727002071 Catalog Number : 9983

Device Description : Sperm Washing Medium

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Sperm Washing Medium - 00893727002088 Catalog Number : 9983

Device Description : Sperm Washing Medium

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 12

Modified Sperm Washing Medium - 00893727002095 Catalog Number : 9984

Device Description : Modified Sperm Washing Medium

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 12

Human Serum Albumin Solution - 00893727002101 Catalog Number : 9988

Device Description : Human Serum Albumin Solution

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 12

CryoTip® - 00893727002118 Catalog Number : 40709

Device Description : CryoTip

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQH

Prescription Use : Yes

Device Count : 5

Hyaluronidase Solution - 00893727002125 Catalog Number : 90101

Device Description : Hyaluronidase

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 5

Embryo Biopsy Medium - 00893727002132 Catalog Number : 90103

Device Description : Embryo Biopsy Medium

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 2

Embryo Freeze Media - 00893727002149 Catalog Number : 90116

Device Class : 2

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

7% PVP Solution with HSA - 00893727002163 Catalog Number : 90121

Device Description : Polyvinylpyrrolidone (PVP) Solution with HSA - 7%

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 5

10% PVP Solution with HSA - 00893727002170 Catalog Number : 90123

Device Description : Polyvinylpyrrolidone (PVP) Solution with HSA - 10%

Device Class :

Duns Number: 057475246

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 5

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