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) (9) Container, Specimen Mailer And Storage, Sterile (KDT) (1)

Premarket Exempt

No Yes

Clear

Alpha-Tec Systems - 00816085020952 Catalog Number : 0004305

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

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

Alpha-Tec Systems - 00816085020969 Catalog Number : 0004306

Device Description : NAC-PAC RED (2.5%) 5x200ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

Alpha-Tec Systems - 00816085020976 Catalog Number : 0004307

Device Description : NAC-PAC RED (2.0%) 5x200ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

Alpha-Tec Systems - 00816085020983 Catalog Number : 0004308

Device Description : NAC-PAC RED (4.0%) 5x200ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

Alpha-Tec Systems - 00816085020990 Catalog Number : 0004309

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

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

Alpha-Tec Systems - 00816085021003 Catalog Number : 0004049

Device Description : Centrifuge Tubes and Caps, 15 mL

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KDT

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085021010 Catalog Number :

Device Description : NAC-PAC RED (4.0%) 50ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085021027 Catalog Number :

Device Description : NAC-PAC RED (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 - 00816085021034 Catalog Number :

Device Description : NAC-PAC RED (2.5%) 200ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085021041 Catalog Number :

Device Description : NAC-PAC RED (2.0%) 200ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

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