L-LACTATE (LAC)

Primary DI
05055273204070
Brand
L-LACTATE (LAC)
Company
RANDOX LABORATORIES LIMITED
Model
LC2839
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

Related Records

Product Codes

CodeName
KHPAcid, Lactic, Enzymatic Method

Product Code Classifications

CodeDeviceSpecialtyClass
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055273204070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273204070050552732040705055273204070

GMDN Terms

TermDefinition
Lactate IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of lactate in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods

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

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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 DIBrandCompanyProduct codePublished
80816042014549FORAFORA CARE INC.KHP2025-05-06
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00850014861537HeartsCare LACTATE TEST STRIPS (25PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
00380740158392ARCHITECTABBOTT IRELANDKHP2024-01-24
00380740158408AlinityABBOTT IRELANDKHP2024-01-24
00816042014505FORAFORA CARE INC.KHP2023-10-31
00850014861360HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2023-08-08
06971674866756BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
06971674866763BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
06971674866770BIOBASEBiobase Biodustry(Shandong)Co., Ltd.KHP2023-07-22
00630414305066Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.KHP2023-05-10
04015630918911Lactate Gen.2Roche Diagnostics GmbHKHP2021-01-18
04015630925148Lactate Gen.2Roche Diagnostics GmbHKHP2021-01-18
04015630926954Lactate Gen.2Roche Diagnostics GmbHKHP2021-01-18
04713648766530THE EDGE Blood Lactate Monitoring SystemAPEX BIOTECHNOLOGY CORP.KHP2021-01-18
04713648766547THE EDGE Blood Lactate Test Strip (non-sterile)APEX BIOTECHNOLOGY CORP.KHP2021-01-18
04713648766554THE EDGE Lactate Control SolutionAPEX BIOTECHNOLOGY CORP.KHP2021-01-18
00054749005505i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
00842768005398Dimension® Flex® reagent cartridge LASiemens Healthcare Diagnostics Inc.KHP2020-09-24
00842768015243Dimension Vista® Flex® reagent cartridge LASiemens Healthcare Diagnostics Inc.KHP2020-09-24
03610230007068Yumizen C1200 LactateHORIBA ABX SASKHP2020-09-09
00380740179199AlinityAbbott GmbHKHP2020-08-28
00630414287270Atellica CH Lactate_2 (Lac_2)Siemens Healthcare Diagnostics Inc.KHP2020-08-19
00630414606095epoc NXS HostEpocal IncKHP2020-06-18
10758750004454VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHP2020-04-18
10758750004911VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHP2020-04-18
07613336121351Lactate Gen.2Roche Diagnostics GmbHKHP2020-03-05
05055273204094L-LACTATE (LAC)RANDOX LABORATORIES LIMITEDKHP2019-06-03
05700699440570S4970 Rinse 1 Solution for 600mL, for ABL7xxRadiometer Medical ApSKHP2018-09-21
05700699441263Cleaning Solution with additive S8375 REF 944-126Radiometer Medical ApSKHP2018-09-21