SARSTEDT, INC.

Address:1025 Saint James Church Rd,NEWTON,NC,28658,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

Blood Specimen Collection Convenience Kit (Excludes Hiv) (PQD) (1) Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) (1)

Premarket Exempt

No Yes

Clear

S-Monovette® - 04038917228305 Catalog Number : 01.1624.001

Device Description : S-Monovette® 8.8 ml ACD-A

Device Class :

Duns Number: 035410179

Premarket Exempt : No

Product Code : JKA

Prescription Use : No

Device Count : 50

S-Monovette® POC Collect Kit - 04038917398763 Catalog Number : 51.5100.100

Device Description : S-Monovette® POC Collect Kit

Device Class :

Duns Number: 035410179

Premarket Exempt : Yes

Product Code : PQD

Prescription Use : No

Device Count : 1

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