EMD Millipore Corporation

Address:28820 SINGLE OAK DR.,TEMECULA,CA,92590,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

Antigen, Cf (Including Cf Control), Cytomegalovirus (GQH) (3) Antiserum, Cf, Varicella-Zoster (GQX) (2) Antisera, Fluorescent, Human Metapneumovirus (OMG) (1) Antisera, Fluorescent, Herpesvirus Hominis 1,2 (GQL) (1) Antiserum, Fluorescent, Rabies Virus (GOI) (1) Pneumocystis Carinii (LYF) (1) Slide Stainer, Automated (KPA) (1)

Premarket Exempt

No Yes

Clear

Light Diagnostics HSV 1 Typing Reagent - 04053252678257 Catalog Number : 5233

Device Description : Light Diagnostics HSV 1 Typing Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQL

Prescription Use : No

Device Count : 1

Light Diagnostics PCP DFA Reagent - 04053252730351 Catalog Number : 5195

Device Description : Light Diagnostics PCP DFA Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : LYF

Prescription Use : No

Device Count : 1

Light Diagnostics Anti-mouse IGG:FITC - 04053252731730 Catalog Number : 5024

Device Description : Light Diagnostics Anti-mouse IGG:FITC

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQH

Prescription Use : No

Device Count : 1

Light Diagnostics VZV DFA Reagent - 04053252732638 Catalog Number : 5094

Device Description : VZV DFA Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQX

Prescription Use : No

Device Count : 1

Light Diagnostics Mouse Anti-CMV Monoclonal Antibody - 04053252737183 Catalog Number : 5026-2ML

Device Description : Light Diagnostics Mouse Anti-CMV Monoclonal Antibody

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQH

Prescription Use : No

Device Count : 1

Light Diagnostics™ Rabies DFA Reagent - 04053252739408 Catalog Number : 5100

Device Description : Rabies DFA Reagent

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GOI

Prescription Use : No

Device Count : 1

Light Diagnostics VZV Control Slide - 04053252792861 Catalog Number : 5088

Device Description : Light Diagnostics VZV Control Slide

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQX

Prescription Use : No

Device Count : 1

MIDAS® III-Plus Automated Stainer - 04061839405141 Catalog Number :

Device Class : 1

Duns Number: 001050152

Premarket Exempt : Yes

Product Code : KPA

Prescription Use : No

Device Count : 1

Light Diagnostics CMV Control Slide - 04061841047445 Catalog Number : 5027

Device Description : Light Diagnostics CMV Control Slide

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : GQH

Prescription Use : No

Device Count : 1

Light Diagnostics hMPV Control Slide - 04061841047452 Catalog Number : 5092

Device Description : Light Diagnostics hMPV Control Slide

Device Class : 2

Duns Number: 829517072

Premarket Exempt : No

Product Code : OMG

Prescription Use : No

Device Count : 1

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