FDA.reportPublic FDA data

Multichem ID-HIV p24

Primary DI
05391523442435
Brand
Multichem ID-HIV p24
Company
TECHNO-PATH MANUFACTURING LIMITED
Model
09915494190
Device description
Multichem ID-HIVp24 is intended for use as a qualitative quality control to monitor the precision of laboratory testing procedures for the HIV-1 p24 antigen detected by theheterogeneous immunoassay systems listed in the Instructions for Use. These products are not intended to replace manufacturer’s recommended controls provided in theirpackage insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Published
2026-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QCHAssayed Quality Control Material For Clinical Microbiology Assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCHAssayed Quality Control Material For Clinical Microbiology AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK2512070

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2512070

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391523442435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391523442435053915234424355391523442435

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.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391523442831Multichem AE06S786106S78612026-06-02
05391523442848Multichem AE06S78622026-06-02
05391523442855Multichem AE06S78632026-06-02
05391523442862Multichem IA Speciality06S78312026-06-02
05391523442879Multichem IA Speciality06S78322026-06-02
05391523442886Multichem IA Speciality06S78332026-06-02
05391523442893Multichem CSF06S78012026-06-02
05391523442909Multichem CSF06S78022026-06-02
05391523442916Multichem NB06S78802026-06-02
05391523442923Multichem D-Dimer06S78912026-06-02
05391523442930Multichem D-Dimer06S78922026-06-02
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
05391523442558 Multichem CSF Plus 10631686190 106316861902026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391523442121Multichem ID-HIV p24 TECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
05391523442251Multichem ID-HIV p24 Mini KitTECHNO-PATH MANUFACTURING LIMITEDQCH2026-05-01
15099590806453Access anti-HAV IgM CalibratorBeckman Coulter, Inc.QCH2026-04-23
00380740197643AlinityAbbott GmbHQCH2023-11-04
00380740174347AlinityAbbott GmbHQCH2022-11-26
08056771602976LIAISON MeMed BV Control SetDiasorin Inc.QCH2022-08-10
00630414607054DV/DM COV2G/CV2G POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QCH2021-01-22
00630414298405DV/DM COV2G/CV2G POS/NEG CTRLSiemens Healthcare Diagnostics Inc.QCH2021-01-22
00630414247014ADVIA Centaur Zika IgM QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414247038ADVIA Centaur Zika Ab QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414286846Atellica IM Zika IgM ControlsSiemens Healthcare Diagnostics Inc.QCH2020-02-24
00630414286860Atellica IM Zika Ab QCSiemens Healthcare Diagnostics Inc.QCH2020-02-24
08056771602648LIAISON® XL Zika Capture IgM II Control SetDiasorin Inc.QCH2019-12-04
07613336129746PreciControl Anti-HAV IIRoche Diagnostics GmbHQCH2019-09-30
00630414587448ADVIA Centaur CMV IgG QCSiemens Healthcare Diagnostics Inc.QCH2019-02-10
00630414246482Atellica IM CMV IgG Quality ControlSiemens Healthcare Diagnostics Inc.QCH2018-11-30