IMMUCOR GTI DIAGNOSTICS, INC.

Address:20925 Crossroads Cir,Waukesha,WI,53186,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

Test,Qualitative,For Hla,Non-Diagnostic (MZI) (9) Instrumentation For Clinical Multiplex Test Systems (NSU) (1)

Premarket Exempt

Clear

Negative Control Serum - 10888234400547 Catalog Number : 628214

Device Description : For Use with LIFECODES LifeScreen Deluxe

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

Conjugate Concentrate - 10888234400561 Catalog Number : 628201

Device Description : For Use with LIFECODES Class I ID and LIFECODES Class II IDv2

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

LIFECODES Wash Buffer - 10888234400578 Catalog Number : 628221

Device Description : For Use with LIFECODES Class I ID and LIFECODES Class II IDv2

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

Positive Control Serum - 10888234400585 Catalog Number : 628208

Device Description : For Use with LIFECODES Class I ID

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

Negative Control Serum - 10888234400592 Catalog Number : 628209

Device Description : For Use with LIFECODES Class I ID

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

Positive Control Serum - 10888234400615 Catalog Number : 403892

Device Description : For Use with LIFECODES Class II IDv2

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

Negative Control Serum - 10888234400622 Catalog Number : 403887

Device Description : For Use with LIFECODES Class II IDv2

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

Dilution Solution - 10888234400745 Catalog Number : 628155

Device Description : For Use with HLA-SSO Typing Kits

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

Dilution Solution - 10888234400769 Catalog Number : 628515

Device Description : For Use with HLA-SSO Typing Kits

Device Class : U

Duns Number: 606034197

Premarket Exempt : No

Product Code : MZI

Prescription Use : Yes

Device Count : 1

LIFECODES Fluoroanalyzer - 10888234401124 Catalog Number : 888302

Device Class : 2

Duns Number: 606034197

Premarket Exempt : No

Product Code : NSU

Prescription Use : Yes

Device Count : 1

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