RICHARD-ALLAN SCIENTIFIC COMPANY

Address:4481 CAMPUS DR.,KALAMAZOO,MI,49008,US

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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

Immunohistochemistry Reagents And Kits (NJT) (10)

Premarket Exempt

No Yes

Clear

Thermo Scientific - 00673693107235 Catalog Number :

Device Description : Monoclonal Mouse Anti- Actin, Smooth Muscle Ab-1, Clone 1A4 ; also known as asm-1

Device Class : 1

Duns Number: 929504710

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Thermo Scientific - 00673693107259 Catalog Number :

Device Description : Monoclonal Mouse Anti- CA 125 (Ovarian Cancer Antigen) Ab-1, Clone Ov185:1

Device Class : 1

Duns Number: 929504710

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Thermo Scientific - 00673693107266 Catalog Number :

Device Description : Monoclonal Mouse Anti- CA 125 (Ovarian Cancer Antigen) Ab-1, Clone Ov185:1

Device Class : 1

Duns Number: 929504710

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Thermo Scientific - 00673693107273 Catalog Number :

Device Description : Monoclonal Mouse Anti-Human GCDFP-15 (Gross Cystic Disease Fluid Protein-15) Ab- Monoclonal Mouse Anti-Human GCDFP-15 (Gross Cystic Disease Fluid Protein-15) Ab-1, Clone 23A3

Device Class : 1

Duns Number: 929504710

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Thermo Scientific - 00673693107280 Catalog Number :

Device Description : Monoclonal Mouse Anti-Human GCDFP-15 (Gross Cystic Disease Fluid Protein-15) Ab- Monoclonal Mouse Anti-Human GCDFP-15 (Gross Cystic Disease Fluid Protein-15) Ab-1, Clone 23A3

Device Class : 1

Duns Number: 929504710

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Thermo Scientific - 00673693107310 Catalog Number :

Device Description : Monoclonal Mouse Anti-Human BCL-2alpha Ab-1, Clone 100/D5

Device Class : 1

Duns Number: 929504710

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Thermo Scientific - 00673693107327 Catalog Number :

Device Description : Monoclonal Mouse Anti-Human BCL-2alpha Ab-1, Clone 100/D5

Device Class : 1

Duns Number: 929504710

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Thermo Scientific - 00673693107358 Catalog Number :

Device Description : Monoclonal Mouse Anti- CD15 Ab-3, Clone MMA; same as LeuM1

Device Class : 1

Duns Number: 929504710

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Thermo Scientific - 00673693107365 Catalog Number :

Device Description : Monoclonal Mouse Anti- CD15 Ab-3, Clone MMA; same as LeuM1

Device Class : 1

Duns Number: 929504710

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

Thermo Scientific - 00673693107372 Catalog Number :

Device Description : Monoclonal Mouse Anti- Vimentin Ab-2, Clone V9

Device Class : 1

Duns Number: 929504710

Premarket Exempt : Yes

Product Code : NJT

Prescription Use : No

Device Count : 1

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