Alpha-TEC Systems, Inc.

Address:1311 SE Cardinal Ct, #170,VANCOUVER,WA,98683,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

General Purpose Reagent (PPM) (3) Supplement, Culture Media (JSK) (3) Culture Media, Non-Propagating Transport (JSM) (1) Quality Control Slides (LJG) (1)

Premarket Exempt

No Yes

Clear

Alpha-Tec Systems - 00816085024059 Catalog Number :

Device Description : NAC-PAC EA3 (3.0%) tray w/ NALC powder

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085024066 Catalog Number : 0004819

Device Description : NAC-PAC EA3 (2.5%) w/ NALC powder

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 60

Alpha-Tec Systems - 00816085024073 Catalog Number : 0004813

Device Description : NAC-PAC EA3 (3.0%) w/ NALC powder

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 60

Alpha-Tec Systems - 00816085024080 Catalog Number : X000489

Device Description : NALC Diluent

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085024097 Catalog Number : 0004820

Device Description : NALC Diluent

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085024110 Catalog Number : 0003267

Device Description : QC1 Malaria Slide

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 10

Alpha-Tec Systems - 00816085024127 Catalog Number : 0003730

Device Description : VTM Viral Transport Medium Pack

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JSM

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085024134 Catalog Number : 0003339

Device Description : Methanol, Absolute

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

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