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) (4) Slides, Microscope (KEW) (2) Supplement, Culture Media (JSK) (2) Fixative, Alcohol Containing (LDZ) (1) Ph Buffer (JCC) (1)

Premarket Exempt

No Yes

Clear

Alpha-Tec Systems - 00816085020075 Catalog Number : S003222

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 : 1

Alpha-Tec Systems - 00816085020105 Catalog Number : S003223

Device Description : CELL-BOND Slide, 1 Red well, no background

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : KEW

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020167 Catalog Number : 0003248S

Device Description : Nocardia Stain Control Slides

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : LJG

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020181 Catalog Number : 0003255S

Device Description : PROTO-FIX QC Slide

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : LDZ

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020259 Catalog Number :

Device Description : NPC-67 Neutralizing Buffer, 250mL bottle

Device Class : 1

Duns Number: 103105524

Premarket Exempt : Yes

Product Code : JCC

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020266 Catalog Number :

Device Description : NAC-PAC RED (3.0%), 50mL

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020273 Catalog Number :

Device Description : NAC-PAC N30 Tray

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : JSK

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020297 Catalog Number : 0003268

Device Description : Trichomonas Quality Control Slide

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 20

Alpha-Tec Systems - 00816085020303 Catalog Number : 0003265S

Device Description : Mycology Quality Control Slide

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 1

Alpha-Tec Systems - 00816085020310 Catalog Number : 0003265

Device Description : Mycology Quality Control Slides

Device Class : 1

Duns Number: 103105524

Premarket Exempt : No

Product Code : LJG

Prescription Use : No

Device Count : 20

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