FDA.reportPublic FDA data

Ketone Serum Controls

Primary DI
00657498002155
Brand
Ketone Serum Controls
Company
STANBIO LABORATORY, L.P.
Model
4010-002
Catalog number
4010-002
Device description
Ketone Serum Controls are intended for use with Ketone tablet tests. These controls are for professional use.
Published
2019-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00657498002155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498002155006574980021556574980021550657498002155

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry enzyme IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple clinical chemistry enzymes.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535techsupport@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
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
00657498001950Procalcitonin LiquiColor2300-0602300-0602017-06-26
00657498000434Albumin LiquiColor®0285-5000285-5002016-09-23
00657498001516Sirrus® Albumin LiquiColor®S0285-750S0285-7502016-09-23
00657498000847Glycated Serum Protein (GSP) LiquiColor®2350-0622350-0622016-09-23
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18
00657498000427Acetaminophen Liquicolor®2400-0602400-0602016-09-23
00657498000441Alkaline Phosphatase LiquiColor®2900-4302900-4302016-09-23
00657498000458Alkaline Phosphatase LiquiColor®2900-5002900-5002016-09-23
00657498000489a-Amylase LiquiColor®2970-4302970-4302016-09-23
00657498000496AST/SGOT Liqui-UV®2920-4302920-4302016-09-23
00657498000502AST/SGOT Liqui-UV®2920-5002920-5002016-09-23
00657498000519B-Hydroxybutyrate LiquiColor®2440-0582440-0582016-09-23

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