FDA.reportPublic FDA data

VITROS

Primary DI
10758750004454
Brand
VITROS
Company
ORTHO-CLINICAL DIAGNOSTICS, INC.
Model
8150112
Catalog number
8150112
Device description
VITROS Chemistry Products LAC Slides
Published
2020-04-18
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
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
10758750004454PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1075875000445410758750004454

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-18 Degrees Celsius-18 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
623873044
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750000340VITROS194392719439272020-05-16
10758750012824ORTHO690457769045762017-03-23
10758750012817ORTHO690457769045772016-08-24
10758750003020BIOCLONE7112207112202014-10-22
10758750003075BIOCLONE7113207113202014-10-22
10758750003129BIOCLONE7115207115202014-10-22
10758750003198BIOCLONE7130807130802014-10-22
10758750003259BIOCLONE7131807131802014-10-22
10758750003266BIOCLONE7140807140802014-10-22
10758750003297BIOCLONE7141807141802014-10-22
10758750003389BIOCLONE7152807152802014-10-22
10758750003662BIOCLONE7173807173802014-10-22
10758750003822ORTHO7190007190002014-10-22
10758750003839SURGISCREEN7191007191002014-10-22
10758750003877AFFIRMAGEN7192017192012014-10-22
10758750003907AFFIRMAGEN7192107192102014-10-22
10758750003914AFFIRMAGEN7192117192112014-10-22
10758750003952ORTHO7193107193102014-10-22
10758750003976RESOLVE7194107194102014-10-22
10758750003990RESOLVE7195107195102014-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850014861407HeartsCare LACTATE TEST STRIPS (10PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
00850014861537HeartsCare LACTATE TEST STRIPS (25PCS/BOX)Hearts Bio, Inc.KHP2024-07-08
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