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

Stains, Microbiologic (JTS) (3) Supplement, Culture Media (JSK) (3) Auramine O (KJK) (2) Carbol Fuchsin (ICL) (1) General Purpose Reagent (PPM) (1)

Premarket Exempt

No Yes

Clear

Alpha-Tec Systems - 00816085020631 Catalog Number : 0004303

Device Description : NAC-PAC RED (3.0%)

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 5

Alpha-Tec Systems - 00816085020655 Catalog Number : 0003359

Device Description : 70% Ethanol

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020709 Catalog Number : X003451

Device Description : M/15 Phosphate Buffer 500ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020716 Catalog Number : X003442

Device Description : M/15 Phosphate Buffer 250ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020778 Catalog Number : 0003527

Device Description : Auramine O Stain 250ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KJK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020785 Catalog Number : 0003528

Device Description : TB Fluorescent Decolorizer 1x250ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JTS

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020792 Catalog Number : 0003529

Device Description : Potassium Permanganate Stain 1x250ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JTS

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020808 Catalog Number : 0003530

Device Description : Auramine O Rhodamine B Stain 250ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KJK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020815 Catalog Number : 0003536

Device Description : Thiazine Red Counterstain 250ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JTS

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020822 Catalog Number : 0003524

Device Description : Kinyoun Carbolfuchsin Stain 250ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : ICL

Prescription Use : No

Device Count : 1

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