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

Supplement, Culture Media (JSK) (5) Ph Buffer (JCC) (4) General Purpose Reagent (PPM) (1)

Premarket Exempt

No Yes

Clear

Alpha-Tec Systems - 00816085023298 Catalog Number : 0003472

Device Description : NAC-PAC (2.5%) 5x50ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

Alpha-Tec Systems - 00816085023304 Catalog Number : 0003480

Device Description : XPR-Plus Neutralizing Buffer 50x50ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JCC

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023311 Catalog Number : 0003481

Device Description : XPR-Plus Neutralizing Buffer 8x250ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JCC

Prescription Use : No

Device Count : 8

Alpha-Tec Systems - 00816085023328 Catalog Number : 0003482

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JCC

Prescription Use : No

Device Count : 10

Alpha-Tec Systems - 00816085023335 Catalog Number : 0003495

Device Description : XPR-Plus Neutralizing Buffer 50x40ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JCC

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023342 Catalog Number : 0003496

Device Description : M/15 Phosphate Buffer 50x40ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023359 Catalog Number : 0003499

Device Description : NAC-PAC (3.0%) 5x200ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

Alpha-Tec Systems - 00816085023366 Catalog Number :

Device Description : NAC-PAC (2.5%) 50ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023373 Catalog Number :

Device Description : NAC-PAC (3.0%) 200ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023403 Catalog Number : 0003510

Device Description : MUCOSOL (Cleland's Reagent) 15x10ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

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