MARKETLAB INC.

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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

Container, Specimen, Non-Sterile (NNI) (4) Container, Specimen, Sterile (FMH) (2) Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (JQC) (1)

Premarket Exempt

No Yes

Clear

Marketlab - 00817517026276 Catalog Number :

Device Description : Easy Open Block Color Specimen Bags, Blue PK100

Device Class : 1

Duns Number: 848917027

Premarket Exempt : Yes

Product Code : NNI

Prescription Use : Yes

Device Count : 1

Marketlab - 00817517026283 Catalog Number :

Device Description : Easy Open Colored Zip Closure Specimen Bags, Yellow PK100

Device Class : 1

Duns Number: 848917027

Premarket Exempt : Yes

Product Code : NNI

Prescription Use : Yes

Device Count : 1

Marketlab - 00817517026290 Catalog Number :

Device Description : Easy Open Colored Zip Closure Specimen Bags, Orange PK100

Device Class : 1

Duns Number: 848917027

Premarket Exempt : Yes

Product Code : NNI

Prescription Use : Yes

Device Count : 1

Marketlab - 00817517026306 Catalog Number :

Device Description : Large Drawstring Specimen Bag - 16"W x 4"D x 18"H - 50/pk

Device Class : 1

Duns Number: 848917027

Premarket Exempt : Yes

Product Code : NNI

Prescription Use : Yes

Device Count : 1

Marketlab - 00817517026573 Catalog Number :

Device Description : Horizon 24 Centrifuge

Device Class : 1

Duns Number: 848917027

Premarket Exempt : Yes

Product Code : JQC

Prescription Use : No

Device Count : 1

Marketlab - 00817517026580 Catalog Number :

Device Description : 90ml Sterile Urine Specimen Cup PK400

Device Class : 1

Duns Number: 848917027

Premarket Exempt : Yes

Product Code : FMH

Prescription Use : No

Device Count : 1

Marketlab - 00817517026597 Catalog Number :

Device Description : 120ml Sterile Urine Specimen Cup PK300

Device Class : 1

Duns Number: 848917027

Premarket Exempt : Yes

Product Code : FMH

Prescription Use : No

Device Count : 1

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