FDA.reportPublic FDA data

LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2)

Primary DI
05055273207118
Brand
LIQUID CHEMISTRY PREMIUM - LEVEL 2 (LIQ CHEM PREMIUM 2)
Company
RANDOX LABORATORIES LIMITED
Model
LUN5048
Published
2019-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273207118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273207118050552732071185055273207118

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyte IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple clinical chemistry analytes, and which together may create a full general biochemistry profile.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273210101Liquid Immunoassay Control – Level 1 (IA CONTROL 1)LIA5142LIA51422025-03-24
05055273210118LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)LIA5143LIA51432025-03-24
05055273210125LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)LIA5144LIA51442025-03-24
05055273219814PTH CONTROL LEVEL 1 (PTH CONTROL 1)PTH10608PTH106082025-03-24
05055273219821PTH CONTROL LEVEL 2 (PTH CONTROL 2)PTH10609PTH106092025-03-24
05055273219838PTH CONTROL LEVEL 3 (PTH CONTROL 3)PTH10610PTH106102025-03-24
05055273219043LIQUID CARDIAC CONTROL 1CQ10534CQ105342025-03-21
05055273219050LIQUID CARDIAC CONTROL 2CQ10535CQ105352025-03-21
05055273219067LIQUID CARDIAC CONTROL 3CQ10536CQ105362025-03-21
05055273219128LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1)CQ10616CQ106162025-03-21
05055273219135LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2)CQ10617CQ106172025-03-21
05055273219142LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3)CQ10618CQ106182025-03-21
05055273219159Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)LAL10565LAL105652025-03-21
05055273219166Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN105662025-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
70845357044432QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2026-02-10
00852720008244Birlinn™ CoV2-Flu-RSV Control Panel M509MmqciOHQ2025-12-04
01220000260634NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-12-01
70845357044340QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
70845357044395QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
05056850400038Mimix™ Quantitative Multiplex FFPE reference standardREVVITY DISCOVERY LIMITEDOHQ2025-08-15
80845357044422Helix Elite Molecular StandardsMICROBIOLOGICS INC.OHQ2025-08-14
01220000260627NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-08-06
04987270235584Lumipulse Infectious Disease ControlsFUJIREBIO INC.OHQ2025-07-31
01220000260481NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-25
08718734962991CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963004CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963011CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963028CueSee® BGEMEurotrol B.V.OHQ2025-07-25
01220000260498NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-23
00850051429578Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429639Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429684Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
05056850400007Mimix™ OncoSpan FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
05056850400014Mimix™ OncoSpan gDNA Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
05056850400021Mimix™ Myeloid Cancer Panel gDNA Reference StandardREVVITY DISCOVERY LIMITEDOHQ2025-06-05
01220000260542NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-03-06
08718734962526CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962618CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962625CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
08718734962632CueSee VeriSTAT®Eurotrol B.V.OHQ2024-10-29
10845357044324Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.OHQ2024-09-04
70845357044364QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2024-09-04
03610522384372Exact DiagnosticsEXACT DIAGNOSTICS, LLCOHQ2024-08-27
03610522384389Exact DiagnosticsEXACT DIAGNOSTICS, LLCOHQ2024-08-27