FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274020944
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
BUN2-1L
Device description
BUN (UREA NITROGEN) LIQUID (1 X 1L)
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDQUrease And Glutamic Dehydrogenase, Urea NitrogenClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817274020944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274020944008172740209448172740209440817274020944

GMDN Terms#

Term, Definition table
TermDefinition
Urea IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.

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
1-305-324-2300customersupport@erbadiagnostics.com

Regulatory Flags#

DUNS number
144968104
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817274022863Drew Scientific6106006106002021-08-20
00817274022832JAS DiagnosticsGLU2-125GLU2-1252018-11-06
00817274022849JAS DiagnosticsAMY2-BULAMY2-BUL2016-10-11
00817274022856JAS DiagnosticsHDL4-250HDL4-2502016-10-11
00817274022825JAS DiagnosticsMICS-10MICS-102018-10-03
00817274022818JAS DiagnosticsMICS-15MICS-152018-09-25
00817274022788JAS DiagnosticsMIA2-20MIA2-202018-07-24
00817274022795JAS DiagnosticsMIAC2-7MIAC2-72018-07-24
00817274022801JAS DiagnosticsMIAS-1MIAS-12018-07-24
00817274022764JAS Diagnostics, incMAG2-125MAG2-1252018-07-19
00817274022771JAS DiagnosticsAMY2-P1LAMY2-P1L2018-07-19
00817274020173Drew Scientific014-3502016-09-09
00817274020258Drew ScientificCA-30EX2016-09-09
00817274020272Drew ScientificEXA-1825N2016-09-09
00817274020289Drew ScientificEXA-25H2016-09-09
00817274020296Drew ScientificEXA-25L2016-09-09
00817274020302Drew ScientificEXA-25N2016-09-09
00817274020319Drew ScientificEXA-3262016-09-09
00817274020326Drew ScientificEXA-339+2016-09-09
00817274020333Drew ScientificEXA-3462016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.CDQ2026-01-23
10673486001228Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
10673486001235Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480TECO DIAGNOSTICSCDQ2023-07-21
10673486001242Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
10673486001259Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
00811727016058Pointe BUN ReagentPOINTE SCIENTIFIC, INC.CDQ2021-01-30
03610230007211Yumizen C1200 UreaHORIBA ABX SASCDQ2020-08-28
00811727015747Pointe BUN on BS480HORIBA INSTRUMENTS INCORPORATEDCDQ2020-05-28
07613336121603Urea/BunRoche Diagnostics GmbHCDQ2020-03-05
00380740161774ARCHITECTAbbott GmbH & Co. KGCDQ2020-01-25
00380740161781ARCHITECTAbbott GmbH & Co. KGCDQ2020-01-25
05055273216172UREARANDOX LABORATORIES LIMITEDCDQ2019-06-03
00386100001988BUN Reagent Kit MEDICA CORPORATIONCDQ2019-02-14
00380740121662AlinityAbbott GmbH & Co. KGCDQ2018-08-31
00380740121679AlinityAbbott GmbH & Co. KGCDQ2018-08-31
00852169008065ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)CLEARCHEM DIAGNOSTICS INC.CDQ2018-04-30
00817274022672JAS DiagnosticsDREW SCIENTIFIC, INC.CDQ2018-04-26
00630414596471Atellica CH UN_cSiemens Healthcare Diagnostics Inc.CDQ2017-12-22
05060500091736Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091743Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091750Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091767Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091774Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091781Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091798Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091804Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
00817302022971CAROLINA LIQUID CHEMISTRIES CORP.® BUN REAGENT PRODUCT NO. DT252CAROLINA LIQUID CHEMISTRIES CORPORATIONCDQ2016-10-17
00812137011916Urea Nitrogen Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.CDQ2016-10-12
00817439020284BUN/BS480Medtest Dx, Inc.CDQ2016-09-27
00817439020291BUN/Polychem 180Medtest Dx, Inc.CDQ2016-09-27