FISHER SCIENTIFIC COMPANY L.L.C.

FISHER SCIENTIFIC COMPANY L.L.C.

Address:300 Industry Dr,PITTSBURGH,PA,15275,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

LATEX AGGLUTINATION ASSAY, RUBELLA (LQN) (4) SYSTEM, TEST, C-REACTIVE PROTEIN (DCN) (2) SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS (KTN) (2) SYSTEM, TEST, RHEUMATOID FACTOR (DHR) (2)

Premarket Exempt

No Yes

Clear

Sure-Vue - 00006136471196 Catalog Number : 23038016

Device Description : Sure-Vue Color Mono 24T

Device Class :

Duns Number: 004321519

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 24

Sure-Vue - 00006136471202 Catalog Number : 23038017

Device Description : Sure-Vue Color Mono 50 T

Device Class :

Duns Number: 004321519

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 50

Sure-Vue - 00006136471219 Catalog Number : 23038004

Device Description : SURE-VUE RUBELLA 100TST/PK

Device Class :

Duns Number: 004321519

Premarket Exempt : No

Product Code : LQN

Prescription Use : Yes

Device Count : 100

Sure-Vue - 00006136471226 Catalog Number : 23038005

Device Description : SURE-VUE RUBELLA 500TST/PK

Device Class :

Duns Number: 004321519

Premarket Exempt : No

Product Code : LQN

Prescription Use : Yes

Device Count : 500

Sure-Vue - 00006136471233 Catalog Number : 23038060

Device Description : Sure-Vue SELECT Rubella 100 T

Device Class :

Duns Number: 004321519

Premarket Exempt : No

Product Code : LQN

Prescription Use : Yes

Device Count : 100

Sure-Vue - 00006136471240 Catalog Number : 23038062

Device Description : SELECT RUBELLA 500 TST/PK

Device Class :

Duns Number: 004321519

Premarket Exempt : No

Product Code : LQN

Prescription Use : Yes

Device Count : 500

Sure-Vue - 00006136471257 Catalog Number : 23038002

Device Description : SURE-VUE RF 100TEST/PK

Device Class :

Duns Number: 004321519

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 100

Sure-Vue - 00006136471264 Catalog Number : 23038003

Device Description : SURE-VUE RF 50TEST/PK

Device Class :

Duns Number: 004321519

Premarket Exempt : No

Product Code : DHR

Prescription Use : Yes

Device Count : 50

Sure-Vue - 00006136471271 Catalog Number : 23038001

Device Description : SURE-VUE CRP 50TEST/PK

Device Class :

Duns Number: 004321519

Premarket Exempt : No

Product Code : DCN

Prescription Use : Yes

Device Count : 50

Sure-Vue - 00006136471288 Catalog Number : 23046389

Device Description : SURE-VUE CRP 500 TESTS/PK

Device Class :

Duns Number: 004321519

Premarket Exempt : No

Product Code : DCN

Prescription Use : Yes

Device Count : 500

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