FDA.reportPublic FDA data

β-Hydroxybutyrate 21 FS

Primary DI
04051839002891
Brand
β-Hydroxybutyrate 21 FS
Company
DiaSys Diagnostic Systems GmbH
Model
137119943018
Catalog number
137119943018
Device description
For the quantitative determination of beta-hydroxybutyrate in human serum or plasma.
Published
2018-11-15
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
JINNitroprusside, Ketones (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04051839002891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04051839002891040518390028914051839002891

GMDN Terms#

Term, Definition table
TermDefinition
Beta-hydroxybutyrate IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of beta-hydroxybutyrate (3-hydroxybutyric acid) in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328419718
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04051839013668DiaSys Procalcitonin FS1731899430181731899430182025-08-01
04051839013675TruLab Procalcitonin Bi-Level Controls5998099430865998099430862025-08-01
04051839013682TruCal Procalcitonin Calibrator Set1731099430821731099430822025-08-01
04051839002907β-Hydroxybutyrate 21 FS1371199430191371199430192018-11-15
04051839002921β-Hydroxybutyrate 21 Bi-Level Controls5954099430845954099430842018-11-15
04051839002938β-Hydroxybutyrate 21 Linearity Standards1372099430521372099430522018-11-15
04051839002914β-Hydroxybutyrate 21 Tri-Level Controls5957099430855957099430852018-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00816042016417FORAFORA CARE INC.JIN2026-03-20
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIN2026-02-06
00860015091642KetoBMKETOBM USA LLCJIN2026-01-19
00199284689879SureMediks B-Ketone Test Strips (25pcs/box)Rasimo Systems LLCJIN2025-12-05
04710469879548XPER Technology Multi-Functional Monitoring System Procheck SmartTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04710469879555XPER Technology Multi-Functional Monitoring System Procheck WittyTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
04719893233841XPER Technology Procheck Witty Procheck Smart B-Ketone Test StripsTAIDOC TECHNOLOGY CORPORATIONJIN2025-10-30
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10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
00850014861575HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-07-02
00850014861056HeartsCare C1 Plus Multi-Functional Monitoring SystemHearts Bio, Inc.JIN2025-03-31
00816042015199FORAFORA CARE INC.JIN2025-03-14
80816042015195FORAFORA CARE INC.JIN2025-03-14
00850054026729QMedix™Diagnostic Automation, Inc.JIN2024-10-29
00816042015069FORAFORA CARE INC.JIN2024-10-01
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80816042015065FORAFORA CARE INC.JIN2024-10-01
80816042015072FORAFORA CARE INC.JIN2024-10-01
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIN2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIN2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIN2024-06-04
00816042015182FORAFORA CARE INC.JIN2024-04-19
80816042015188FORAFORA CARE INC.JIN2024-04-19