Home GUDID 00380740158392 ARCHITECT
Primary DI 00380740158392
Brand ARCHITECT
Company ABBOTT IRELAND
Model 04T3020
Catalog number 04T3020
Device description Lactic Acid2 400 Tests
Published 2024-01-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KHP ACID, LACTIC, ENZYMATIC METHOD
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KHP Acid, Lactic, Enzymatic Method Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00380740158392 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00380740158392 00380740158392 380740158392 0380740158392
GMDN Terms# Term, Definition table Term Definition Lactate IVD, kit, spectrophotometry A 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 a spectrophotometry method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 989964119 Device count 1 Premarket exempt true Kit true Lot or batch 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 00816042014543 FORA FORA CARE INC. KHP 2025-05-06 80816042014549 FORA FORA CARE INC. KHP 2025-05-06 00850014861407 HeartsCare LACTATE TEST STRIPS (10PCS/BOX) Hearts Bio, Inc. KHP 2024-07-08 00850014861537 HeartsCare LACTATE TEST STRIPS (25PCS/BOX) Hearts Bio, Inc. KHP 2024-07-08 05700699460509 SC90 50 BG, LYT, MET, OXI + QC Radiometer Medical ApS KHP 2024-07-01 00380740158408 Alinity ABBOTT IRELAND KHP 2024-01-24 00816042014505 FORA FORA CARE INC. KHP 2023-10-31 00850014861360 HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX) Hearts Bio, Inc. KHP 2023-08-08 06971674866756 BIOBASE Biobase Biodustry(Shandong)Co., Ltd. KHP 2023-07-22 06971674866763 BIOBASE Biobase Biodustry(Shandong)Co., Ltd. KHP 2023-07-22 06971674866770 BIOBASE Biobase Biodustry(Shandong)Co., Ltd. KHP 2023-07-22 00630414610979 Atellica CH Lactate_3 Siemens Healthcare Diagnostics Inc. KHP 2023-05-10 00630414305066 Atellica CH Lactate_3 Siemens Healthcare Diagnostics Inc. KHP 2023-05-10 10385480408131 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 00385480408141 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 00385480408158 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 00385480626248 Lactate Plus NOVA BIOMEDICAL CORPORATION KHP 2022-12-08 10054749005502 i-STAT ABBOTT POINT OF CARE INC. KHP 2020-10-05 00054749005505 i-STAT ABBOTT POINT OF CARE INC. KHP 2020-10-05 00630414606460 epoc Host2 Epocal Inc KHP 2020-07-15 00630414286143 RAPIDPoint® 500e Blood Gas System Siemens Healthcare Diagnostics Inc. KHP 2020-04-15 05700699441362 S8377 REF 944-136 *6 Cleaning solution Met II Solution Radiometer Medical ApS KHP 2018-09-21 05700699055903 Disposable Waste Container D512 REF 905-590 Radiometer Medical ApS KHP 2018-09-21 05700699058027 Disposable Waste Container D513 REF 905-802 Radiometer Medical ApS KHP 2018-09-21 05700699059178 REF 905-917 ABL90 FLEX sBOX Radiometer Medical ApS KHP 2018-09-21 05700699059185 905-918 ABL90 FLEX flush device Radiometer Medical ApS KHP 2018-09-21 05700699059567 REF 905-956 ABL90 FLEX sBOX PLUS Radiometer Medical ApS KHP 2018-09-21 05700699250476 925-047 ABL90 FLEX inlet clip Radiometer Medical ApS KHP 2018-09-21 05700699439062 S5362 REF 943-906 Radiometer Medical ApS KHP 2018-09-21 05700699441232 Cleaning Solution with additive S7375 REF 944-123 Radiometer Medical ApS KHP 2018-09-21
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