FDA.reportPublic FDA data

Multichem S Plus

Primary DI
05391523440554
Brand
Multichem S Plus
Company
TECHNO-PATH MANUFACTURING LIMITED
Model
CH110PLA.05
Published
2022-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391523440554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391523440554053915234405545391523440554

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
896365983
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391523442770Multichem AEAE621A2026-05-11
05391523442787Multichem AEAE622A2026-05-11
05391523442794Multichem AEAE623A2026-05-11
05391523442800Multichem AE AE621X2026-05-11
05391523442817Multichem AE AE622X2026-05-11
05391523442824Multichem AE AE623X2026-05-11
05391523442121Multichem ID-HIV p24 SR111U2026-05-01
05391523442251Multichem ID-HIV p24 Mini KitSR111MU2026-05-01
05391523442435Multichem ID-HIV p24 099154941902026-05-01
05391523442558 Multichem CSF Plus 10631686190 106316861902026-03-23
05391523442565 Multichem CSF Plus 10631716190106317161902026-03-23
05391523442572Multichem AEC10631627190106316271902026-03-23
05391523442589Multichem AEC10631643190106316431902026-03-23
05391523442596Multichem AEC10631651190106316511902026-03-23
05391523442602Multichem IA SET A10631732190106317321902026-03-23
05391523442619Multichem IA SET A 10631759190 106317591902026-03-23
05391523442626Multichem IA SET A 10631767190 106317671902026-03-23
05391523442473Multichem MS Free TDMs10162066190101620661902025-06-17
05391523442480Multichem MS Free TDMs10162074190101620741902025-06-17
05391523442381 Multichem MS ISDs09922563190099225631902025-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
00850011135747VALIDATELgc Clinical Diagnostics, Inc.JJY2026-04-24
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850051429905Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
00850051429912Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
00850051429929Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
05056850400052Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2026-03-27
05056850400069Mimix™ Geni™ Negative FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2026-03-27
01220000260641NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2026-03-25
00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135839VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
01220000260450NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-09-10
01220000260467NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-09-10
08718734962946CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734962953CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734962960CueSee® BGEMEurotrol B.V.OHQ2025-07-25