APEX BIOTECHNOLOGY CORP.

Address:NO. 7, LI-HSIN ROAD V,,HSINCHU,TW

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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

Acid, Uric, Acid Reduction Of Ferric Ion (LFQ) (4) Acid, Lactic, Enzymatic Method (KHP) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Multiple Use Blood Lancet For Single Patient Use Only (QRL) (1) Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (QRK) (1)

Premarket Exempt

No Yes

Clear

UASure II Blood Uric Acid Monitoring System - 00886338000031 Catalog Number : S95046

Device Description : Complete Kit

Device Class : 1

Duns Number: 657608092

Premarket Exempt : Yes

Product Code : LFQ

Prescription Use : No

Device Count : 1

UASure II Blood Uric Acid Test Strips 25s - 00886338000048 Catalog Number : S5640997

Device Description : 25s foil packet

Device Class : 1

Duns Number: 657608092

Premarket Exempt : Yes

Product Code : LFQ

Prescription Use : No

Device Count : 25

UASure II Uric Acid Control Solution L1 - 00886338000055 Catalog Number : S5800397

Device Description : Level 1

Device Class : 1

Duns Number: 657608092

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

UASure Blood Uric Acid Monitoring Meter - 04713648766462 Catalog Number :

Device Description : Kit (5s)

Device Class : 1

Duns Number: 657608092

Premarket Exempt : Yes

Product Code : LFQ

Prescription Use : No

Device Count : 1

UASure Blood Uric Acid Test Strip - 04713648766479 Catalog Number :

Device Description : 25s

Device Class : 1

Duns Number: 657608092

Premarket Exempt : Yes

Product Code : LFQ

Prescription Use : No

Device Count : 1

UASure uric acid control solution - 04713648766486 Catalog Number :

Device Class : 1

Duns Number: 657608092

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

ApexBio SteriLance BLOOD LANCET (Sterile) - 04713648766493 Catalog Number :

Device Class : 2

Duns Number: 657608092

Premarket Exempt : No

Product Code : QRK, QRL

Prescription Use : No

Device Count : 1

THE EDGE Blood Lactate Monitoring System - 04713648766530 Catalog Number :

Device Description : KIT

Device Class : 1

Duns Number: 657608092

Premarket Exempt : Yes

Product Code : KHP

Prescription Use : No

Device Count : 1

THE EDGE Blood Lactate Test Strip (non-sterile) - 04713648766547 Catalog Number :

Device Description : 25s

Device Class : 1

Duns Number: 657608092

Premarket Exempt : Yes

Product Code : KHP

Prescription Use : No

Device Count : 1

THE EDGE Lactate Control Solution - 04713648766554 Catalog Number :

Device Class : 1

Duns Number: 657608092

Premarket Exempt : Yes

Product Code : KHP

Prescription Use : No

Device Count : 1

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