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

Quality Control Slides (LJG) (9) Slides, Microscope (KEW) (1)

Premarket Exempt

No Yes

Clear

Alpha-Tec Systems - 00816085020433 Catalog Number : 0003222

Device Description : CELL-BOND Slides, 2 wells [15mm], red background

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KEW

Prescription Use : No

Device Count : 100

Alpha-Tec Systems - 00816085020440 Catalog Number : 0003233

Device Description : Gram Stain QC Slides (10 Pk)

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 10

Alpha-Tec Systems - 00816085020457 Catalog Number : 0003230

Device Description : Gram Stain QC Slide

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 40

Alpha-Tec Systems - 00816085020464 Catalog Number : 0003231

Device Description : Gram Stain QC Slides with one specimen well

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 40

Alpha-Tec Systems - 00816085020471 Catalog Number : 0003236

Device Description : Gram Stain Control Slides With 3 Patient Wells

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 10

Alpha-Tec Systems - 00816085020488 Catalog Number : 0003235

Device Description : Gram Stain Control Slides With 3 Patient Wells

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 40

Alpha-Tec Systems - 00816085020495 Catalog Number : 0003238

Device Description : Gram Stain Control Slide

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 40

Alpha-Tec Systems - 00816085020501 Catalog Number : 0003243

Device Description : AFB Stain Control Slides

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 10

Alpha-Tec Systems - 00816085020518 Catalog Number : 0003240

Device Description : AFB Stain Control Slides

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 40

Alpha-Tec Systems - 00816085020525 Catalog Number : 0003245

Device Description : AFB Stain Control Slides

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 40

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