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) (4) General Purpose Reagent (PPM) (3) Stains, Microbiologic (JTS) (2) Carbol Fuchsin (ICL) (1)

Premarket Exempt

No Yes

Clear

Alpha-Tec Systems - 00816085020839 Catalog Number : 0003525

Device Description : TB Decolorizer 250ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JTS

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020846 Catalog Number : 0003526

Device Description : Methylene Blue Counterstain 250ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JTS

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020853 Catalog Number : 0003531

Device Description : Ziehl-Neelsen Carbolfuchsin Stain 250ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : ICL

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020877 Catalog Number : X000020

Device Description : NALC tablets 1x10ea

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020884 Catalog Number : X003441

Device Description : .25g Cysteine

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020891 Catalog Number : X003457

Device Description : 1g Cysteine

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020914 Catalog Number :

Device Description : NAC-PAC RED (2.0%) 50ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020921 Catalog Number : 0004302

Device Description : NAC-PAC RED (2.0%) 5x50ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

Alpha-Tec Systems - 00816085020938 Catalog Number : 0004303

Device Description : NAC-PAC RED (3.0%) 5x50ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

Alpha-Tec Systems - 00816085020945 Catalog Number : 0004304

Device Description : NAC-PAC RED (4.0%) 5x50ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

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