Home GUDID 10758750001545 VITROS
Primary DI 10758750001545
Brand VITROS
Company ORTHO CLINICAL DIAGNOSTICS
Model 6801863
Catalog number 6801863
Device description VITROS Immunodiagnostic Products Anti-HIV 1 + 2 Controls
Published 2020-04-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name JJX Single (specified) analyte controls (assayed and unassayed) OHQ Multi-analyte controls unassayed
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry 1 OHQ Multi-Analyte Controls Unassayed Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20758750001542 Package GS1 30 In Commercial Distribution 10758750001545 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20758750001542 20758750001542 10758750001545 10758750001545
GMDN Terms# Term, Definition table Term Definition HIV1/HIV2 antibody IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 May be stored frozen, avoid repeated freeze-thaw cycles Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 215865786 Device count 1 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07613336234457 PreciControl Syphilis Roche Diagnostics GmbH JJX 2026-05-15 30732671309403 Pip AMITY HOLDINGS, LLC JJX 2026-04-16 10612479280509 McKesson MCKESSON MEDICAL-SURGICAL INC. JJX 2025-12-01 10840330706541 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2025-11-25 00021292015398 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2025-10-02 00021292015404 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2025-10-02 00021292015411 TRUE METRIX TRIVIDIA HEALTH, INC. JJX 2025-10-02 08058056685407 Cystatin C Controls SENTINEL CH. SPA JJX 2025-09-16 08718734962946 CueSee® BGEM Eurotrol B.V. OHQ 2025-07-25 08718734962953 CueSee® BGEM Eurotrol B.V. OHQ 2025-07-25 08718734962960 CueSee® BGEM Eurotrol B.V. OHQ 2025-07-25 80845357044415 QC Sets and Panels: Helix Elite™ MICROBIOLOGICS INC. OHQ 2025-05-27 10758750035380 VITROS ORTHO CLINICAL DIAGNOSTICS JJX 2025-05-20 08718734962533 CueSee VeriSTAT® Eurotrol B.V. OHQ 2024-10-29 08718734962540 CueSee VeriSTAT® Eurotrol B.V. OHQ 2024-10-29 10758750035076 VITROS ORTHO CLINICAL DIAGNOSTICS JJX 2024-09-18 00021292015091 TRUENESS TRIVIDIA HEALTH, INC. JJX 2024-04-03 00021292015107 TRUENESS TRIVIDIA HEALTH, INC. JJX 2024-04-03 07613336166338 PreciControl beta-Amyloid (1-42) II Roche Diagnostics GmbH JJX 2022-12-13 07613336180860 CalCheck beta-Amyloid (1-42) II Roche Diagnostics GmbH JJX 2022-12-13 10673486000719 TECO DIAGNOSTICS TECO DIAGNOSTICS JJX 2022-08-09 00021292008420 TRUE FOCUS TRIVIDIA HEALTH, INC. JJX 2021-02-26 00021292008437 TRUE FOCUS TRIVIDIA HEALTH, INC. JJX 2021-02-26 00021292008444 TRUE FOCUS TRIVIDIA HEALTH, INC. JJX 2021-02-26 00021292008369 TRUEcontrol TRIVIDIA HEALTH, INC. JJX 2021-01-29 00021292008383 TRUEcontrol TRIVIDIA HEALTH, INC. JJX 2021-01-29 14987481164441 uTASWako AFP-L3 Control L FUJIFILM WAKO PURE CHEMICAL CORPORATION JJX 2020-10-23 14987481164458 uTASWako AFP-L3 Control H FUJIFILM WAKO PURE CHEMICAL CORPORATION JJX 2020-10-23 14987481164489 uTASWako DCP Control L FUJIFILM WAKO PURE CHEMICAL CORPORATION JJX 2020-10-23 14987481164496 uTASWako DCP Control H FUJIFILM WAKO PURE CHEMICAL CORPORATION JJX 2020-10-23