VITROLIFE INC.

Address:3601 South Inca Street,Englewood,CO,80110,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) (4) Semen Analysis Device (POV) (3) Sperm, Antigen, Antiserum, Control (DFQ) (1)

Premarket Exempt

No Yes

Clear

Enhance-S Plus HEPES HTF - 00805360016803 Catalog Number :

Device Description : 1-(100ml/lower%)

Device Class : 2

Duns Number: 051915038

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Enhance Sperm Wash - 00805360016827 Catalog Number :

Device Description : 1-(500ml) Sperm Wash Modified HTF Medium

Device Class : 2

Duns Number: 051915038

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Enhance Sperm Wash with Gentamicin - 00805360016841 Catalog Number :

Device Description : 1-(100ml) Sperm Wash Modified HTF Medium w/Gentamicin

Device Class : 2

Duns Number: 051915038

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Enhance Sperm Wash w/ Gentamicin - 00805360016865 Catalog Number :

Device Description : 1-(500ml) Enhance Sperm Wash w/ Gentamicin

Device Class : 2

Duns Number: 051915038

Premarket Exempt : No

Product Code : MQL

Prescription Use : Yes

Device Count : 1

Leucoscreen Plus Test Kit - 00805360016988 Catalog Number :

Device Description : Leucoscreen Plus Test Kit, 20 tests per kit

Device Class :

Duns Number: 051915038

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Leucoscreen Test Kit - 00805360017992 Catalog Number :

Device Description : Leucoscreen Test Kit, 20 tests per kit

Device Class :

Duns Number: 051915038

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

SpermMar IgA Latex Particles - 00805360018388 Catalog Number :

Device Description : SpermMar IgA Latex Particles

Device Class : 1

Duns Number: 051915038

Premarket Exempt : Yes

Product Code : DFQ

Prescription Use : No

Device Count : 1

Spermac Stain - 00805360018395 Catalog Number :

Device Description : Spermac Stain, 50mL

Device Class : 2

Duns Number: 051915038

Premarket Exempt : Yes

Product Code : POV

Prescription Use : No

Device Count : 1

Spermac Stain - 00805360018401 Catalog Number :

Device Description : Spermac Stain, 250mL

Device Class : 2

Duns Number: 051915038

Premarket Exempt : Yes

Product Code : POV

Prescription Use : No

Device Count : 1

Spermac Stain - Fixative - 00805360018418 Catalog Number :

Device Description : Spermac Stain - Fixative, 250mL

Device Class : 2

Duns Number: 051915038

Premarket Exempt : Yes

Product Code : POV

Prescription Use : No

Device Count : 1

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