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) (5) Auramine O (KJK) (2) Carbol Fuchsin (ICL) (2) Clinical Sample Concentrator (JJH) (1)

Premarket Exempt

No Yes

Clear

Alpha-Tec Systems - 00816085023458 Catalog Number : 0003524C

Device Description : Kinyoun Carbolfuchsin Stain 8x250ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : ICL

Prescription Use : No

Device Count : 8

Alpha-Tec Systems - 00816085023472 Catalog Number : 0003525C

Device Description : TB Decolorizer 8x250ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JTS

Prescription Use : No

Device Count : 8

Alpha-Tec Systems - 00816085023496 Catalog Number : 0003526C

Device Description : Methylene Blue Counterstain 8x250ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JTS

Prescription Use : No

Device Count : 8

Alpha-Tec Systems - 00816085023519 Catalog Number : 0003527C

Device Description : Auramine O Fluorescent Stain 8x250ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KJK

Prescription Use : No

Device Count : 8

Alpha-Tec Systems - 00816085023533 Catalog Number : 0003528C

Device Description : TB Fluorescent Decolorizer 8x250ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JTS

Prescription Use : No

Device Count : 8

Alpha-Tec Systems - 00816085023557 Catalog Number : 0003529C

Device Description : Potassium Permanganate Counterstain 8x250ml bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JTS

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023571 Catalog Number : 0003530C

Device Description : Auramine O/Rhodamine B Stain 8x250ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KJK

Prescription Use : No

Device Count : 8

Alpha-Tec Systems - 00816085023595 Catalog Number : 0003531C

Device Description : Ziehl-Neelsen Carbolfushsin Stain 8x250ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : ICL

Prescription Use : No

Device Count : 8

Alpha-Tec Systems - 00816085023625 Catalog Number : 0003535

Device Description : Nocardia/Actinomyces Stain Set

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JTS

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023632 Catalog Number : 0004044

Device Description : PRS Parasite Recovery System (Filtration units only)

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JJH

Prescription Use : No

Device Count : 1

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