Description and Specificity

Regulatory

Status*

Presentation

Item Number

THROMBOPHILIA

Lupus Anticoagulant

HEMOCLOT LA Check (6x10 tests)

RUO

6x10 tests

ACK090K

HEMOCLOT LA Check (6x50 tests)

RUO

6x50 tests

ACK090L

HEMOCLOT LA Verify (6x10 tests)

RUO

6x10 tests

ACK091K

HEPARIN KITS AND HIT ASSAYS

Measurement of Heparin and Heparin-Like Substances

BIOPHEN Heparin 3

CE, HC

510(k)

3x30 tests

A221003

BIOPHEN Heparin 6

CE, HC

510(k)

4x60 tests

A221006

BIOPHEN Heparin (AT+)

RUO

2x60 tests

A221007

BIOPHEN Heparin Anti-Xa

(2 stages) USP/EP)

USP/EP

2 x100 tests

A221010-USP

BIOPHEN Heparin (LRT)

CE, HC

4x7.5 ml

A221011

BIOPHEN HEPARIN (LRT) (3x3 ml)

CE

3x3 ml

A221013

BIOPHEN Heparin Anti-IIa (Kinetics)

RUO

2x250 tests

A221020

BIOPHEN Heparin Anti-IIa

(2 Stages) USP/EP)

USP/EP

2x100 tests

A221025-USP

Diagnosis of Heparin Induced Thrombocytopenia (HIT)

ZYMUTEST Anti VIII IgG MonoStrip IgG -

Isotype

RUO

4x8 test kit

ARK039A

ZYMUTEST HIA IgG

CE, HC

510(k)

12x8 test kit

ARK040A

ZYMUTEST HIA IgM

CE, HC

12x8 test kit

ARK040B

ZYMUTEST HIA IgA

CE, HC

12x8 test kit

ARK040C

ZYMUTEST HIA IgGAM

CE, HC

510(k)

12x8 test kit

ARK040D

ZYMUTEST HIA IgG, IgA, IgM

CE, HC

12x8 test kit

ARK040E

Wash solution

RUO

1x50 ml

AAR011A

Wash solution

RUO

3x50 ml

AAR011K

HIT Controls for IgA

RUO

1 ml

ACIA001

HIT Controls for IgG

RUO

1 ml

ACIG001

HIT Controls for IgM

RUO

1 ml

ACIM001

Mono Strip Disposable HIT

ZYMUTEST HIA Mono Strip, IgG

CE, 510(k)

4x8 well strips

ARK041A

ZYMUTEST HIA Mono strip, IgGAM

CE, 510(k)

4x8 well strips

ARK041D