FDA.reportPublic FDA data

BIOBASE

Primary DI
06971674866770
Brand
BIOBASE
Company
Biobase Biodustry(Shandong)Co., Ltd.
Model
R1:18mL×1 R2:6mL×1
Published
2023-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KHPAcid, Lactic, Enzymatic Method

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971674866770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971674866770069716748667706971674866770

GMDN Terms#

Term, Definition table
TermDefinition
Lactate IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of lactate in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420046355
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936895315780BIOBASEDBI-32026-07-30
06936895300298BIOBASEBK5002023-07-04
06971674861201BIOBASEBK12002023-07-04
06971674861218BIOBASEBK6002023-07-04
06971674861225BIOBASEBK4002023-07-04
06971674861232BIOBASEBK2802023-07-04
06971674861249BIOBASEBK2002023-07-04
06971674866664BIOBASER1:60mL×2 R2:20mL×22023-07-22
06971674866671BIOBASER1:18mL×4 R2:6mL×42023-07-22
06971674866688BIOBASER1:18mL×1 R2:6mL×12023-07-22
06971674867920BIOBASECalibrator: 1mL×12023-07-22
06971674868255BIOBASEControl: 1mL×12023-07-22
06971674866190BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866206BIOBASER1:40mL×2 R2:20mL×22023-07-22
06971674866213BIOBASER1:20mL×4 R2:10mL×42023-07-22
06971674866220BIOBASER1:20mL×1 R2:10mL×12023-07-22
06971674866237BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866244BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674866251BIOBASER1:50mL×2 R2:25mL×22023-07-22
06971674868231BIOBASEControl:1mL×12023-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719893239003XPER Technology Lactate Monitoring System L1TAIDOC TECHNOLOGY CORPORATIONKHP2026-08-03
04719893239010XPER Technology Lactate Test Strips L1 (25pcs/box)TAIDOC TECHNOLOGY CORPORATIONKHP2026-08-03
05700693930978ABL90 FLEXRadiometer Medical ApSKHP2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSKHP2026-07-09
05700699446572SP90Radiometer Medical ApSKHP2026-07-09
05700699447579SP90Radiometer Medical ApSKHP2026-07-09
05700699461056SC90Radiometer Medical ApSKHP2026-07-09
05700699461087SC90Radiometer Medical ApSKHP2026-07-09
05700699461094SC90Radiometer Medical ApSKHP2026-07-09
05700699461100SC90Radiometer Medical ApSKHP2026-07-09
05700699461605SC90Radiometer Medical ApSKHP2026-07-09
00816042014543FORAFORA CARE INC.KHP2025-05-06
80816042014549FORAFORA CARE INC.KHP2025-05-06
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSKHP2024-07-01
00630414610979Atellica CH Lactate_3Siemens Healthcare Diagnostics Inc.KHP2023-05-10
10385480408131Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408141Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480408158Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
00385480626248Lactate PlusNOVA BIOMEDICAL CORPORATIONKHP2022-12-08
10054749005502i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
00630414606460epoc Host2Epocal IncKHP2020-07-15
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.KHP2020-04-15
05700699441362S8377 REF 944-136 *6 Cleaning solution Met II SolutionRadiometer Medical ApSKHP2018-09-21
05700699055903Disposable Waste Container D512 REF 905-590Radiometer Medical ApSKHP2018-09-21
05700699058027Disposable Waste Container D513 REF 905-802Radiometer Medical ApSKHP2018-09-21
05700699059178REF 905-917 ABL90 FLEX sBOXRadiometer Medical ApSKHP2018-09-21
05700699059185905-918 ABL90 FLEX flush deviceRadiometer Medical ApSKHP2018-09-21
05700699059567REF 905-956 ABL90 FLEX sBOX PLUSRadiometer Medical ApSKHP2018-09-21
05700699250476925-047 ABL90 FLEX inlet clipRadiometer Medical ApSKHP2018-09-21
05700699439062S5362 REF 943-906Radiometer Medical ApSKHP2018-09-21