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

Container, Specimen Mailer And Storage, Sterile (KDT) (4) General Purpose Reagent (PPM) (3) Supplement, Culture Media (JSK) (2) Kit, Identification, Mycobacteria (JSY) (1)

Premarket Exempt

No Yes

Clear

Alpha-Tec Systems - 00816085023793 Catalog Number : 0003358

Device Description : Triton X-100 20%

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023809 Catalog Number : 0001350

Device Description : Centrifuge Tubes, 50 mL, 20 Bags x 25 Tubes

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KDT

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023823 Catalog Number : 0001516

Device Description : Centrifuge Tubes, 15 mL, 20 Trays x 25 Tubes

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KDT

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023830 Catalog Number : 0001518

Device Description : Centrifuge Tubes, 15 mL, 20 Bags x 25 Tubes

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KDT

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023847 Catalog Number : 0001352

Device Description : Centrifuge Tubes, 50 mL, 20 Bags x 25 Tubes

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KDT

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085023861 Catalog Number : 0003470

Device Description : Bovine Albumin Fraction V 10x10ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSY

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085024011 Catalog Number : 0003521

Device Description : 0.9% Saline 5.0ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085024028 Catalog Number : 0003520

Device Description : 0.9% Saline 4.5ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085024035 Catalog Number : 0003516

Device Description : 0.9% Saline 4.0ml

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : PPM

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085024042 Catalog Number :

Device Description : NAC-PAC EA3 (2.5%) tray w/ NALC powder

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

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