BIOTECH INCORPORATED

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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

Labware, Assisted Reproduction (MQK) (10)

Premarket Exempt

Clear

Cryolock - B056CLRCT1 Catalog Number : CL-R-CT

Device Description : Cryopreservation storage device that is intended for use in vitrification proced Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Class :

Duns Number: 080129843

Premarket Exempt : No

Product Code : MQK

Prescription Use : Yes

Device Count : 5

Cryolock(B) - B056CLRCTB1 Catalog Number : CL-R-CT (Blue)

Device Description : Cryolock - BlueCryopreservation Storage Device that is intended for use in vitri Cryolock - BlueCryopreservation Storage Device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Class :

Duns Number: 080129843

Premarket Exempt : No

Product Code : MQK

Prescription Use : Yes

Device Count : 5

CRYOLOCK(C) - B056CLRCTC1 Catalog Number : CL-R-CT (Clear)

Device Description : Cryolock - ClearCryopreservation storage device that is intended for use in vitr Cryolock - ClearCryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Class :

Duns Number: 080129843

Premarket Exempt : No

Product Code : MQK

Prescription Use : Yes

Device Count : 5

Cryolock(G) - B056CLRCTG1 Catalog Number : CL-R-CT (Green)

Device Description : Cryolock - GreenCryopreservation storage device that is intended for use in vitr Cryolock - GreenCryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Class :

Duns Number: 080129843

Premarket Exempt : No

Product Code : MQK

Prescription Use : Yes

Device Count : 5

CRYOLOCK(O) - B056CLRCTO1 Catalog Number : CL-R-CT (Orange)

Device Description : Cryolock - OrangeCryopreservation storage device that is intended for use in vit Cryolock - OrangeCryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Class :

Duns Number: 080129843

Premarket Exempt : No

Product Code : MQK

Prescription Use : Yes

Device Count : 5

CRYOLOCK(Y) - B056CLRCTY1 Catalog Number : CL-R-CT (Yellow)

Device Description : Cryolock - YellowCryopreservation storage device that is intended for use in vit Cryolock - YellowCryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Class :

Duns Number: 080129843

Premarket Exempt : No

Product Code : MQK

Prescription Use : Yes

Device Count : 5

S-CRYOLOCK (B) - B056SCLB1 Catalog Number : S-CL (BLUE)

Device Description : S-CRYOLOCK - BLUE - Cryopreservation storage device that is intended for use in S-CRYOLOCK - BLUE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Class :

Duns Number: 080129843

Premarket Exempt : No

Product Code : MQK

Prescription Use : Yes

Device Count : 5

S-CRYOLOCK (C) - B056SCLC1 Catalog Number : S-CL (CLEAR)

Device Description : S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Class :

Duns Number: 080129843

Premarket Exempt : No

Product Code : MQK

Prescription Use : Yes

Device Count : 5

S-CRYOLOCK (G) - B056SCLG1 Catalog Number : S-CL (GREEN)

Device Description : S-CRYOLOCK - GREEN - Cryopreservation storage device that is intended for use in S-CRYOLOCK - GREEN - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Class :

Duns Number: 080129843

Premarket Exempt : No

Product Code : MQK

Prescription Use : Yes

Device Count : 5

S-CRYOLOCK (O) - B056SCLO1 Catalog Number : S-CL (ORANGE)

Device Description : S-CRYOLOCK - ORANGE - Cryopreservation storage device that is intended for use i S-CRYOLOCK - ORANGE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos

Device Class :

Duns Number: 080129843

Premarket Exempt : No

Product Code : MQK

Prescription Use : Yes

Device Count : 5

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