FDA.report

JAS Diagnostics

Primary DI
00817274021187
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
CHO2-125
Device description
CHOLESTEROL LIQ (2x 125mL)
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

Related Records

Contact Domains

Product Codes

CodeName
CHHEnzymatic Esterase--Oxidase, Cholesterol

Product Code Classifications

CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817274021187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274021187008172740211878172740211870817274021187

GMDN Terms

TermDefinition
Total cholesterol lipid IVD, kit, chemiluminescent immunoassay, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative measurement of total cholesterol lipid in a clinical specimen within a short period relative to standard laboratory testing procedures, using a chemiluminescent immunoassay method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
144968104
Device count
1
DM exempt
false
Premarket exempt
true
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 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 DIBrandCompanyProduct codePublished
10682607690098Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TAcon Laboratories, Inc.CHH2026-03-09
10381934770014CholesterolPOLYMER TECHNOLOGY SYSTEMS, INC.CHH2025-06-16
00380740158125AlinityABBOTT IRELANDCHH2025-04-15
00380740158132ARCHITECTABBOTT IRELANDCHH2025-04-15
00380740158149ARCHITECTABBOTT IRELANDCHH2025-04-15
80816042015201FORAFORA CARE INC.CHH2025-03-14
06935740726986Blood Lipid Test StripUrit Medical Electronic Co., Ltd.CHH2024-07-12
08806141303701Newfoundland Cholesterol TestDFI CO.,LTDCHH2024-05-29
00893038002883Cholestech LDX™ALERE SAN DIEGO, INC.CHH2023-12-20
00893038002890Cholestech LDX™ALERE SAN DIEGO, INC.CHH2023-12-20
00893038002906Cholestech LDX™ALERE SAN DIEGO, INC.CHH2023-12-20
00816042014482FORAFORA CARE INC.CHH2023-10-31
10673486001419Teco Diagnostics Cholesterol TC-Matrix-240TECO DIAGNOSTICSCHH2023-08-01
10673486001426Teco Diagnostics Cholesterol TC-Matrix-480TECO DIAGNOSTICSCHH2023-08-01
06936895301882BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHH2023-07-26
06936895301899BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHH2023-07-26
06936895301905BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHH2023-07-26
06936895301912BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CHH2023-07-26
10673486001457Teco Diagnostics Cholesterol Reagent SetTECO DIAGNOSTICSCHH2023-07-26
10673486001464Teco Diagnostics Cholesterol Reagent SetTECO DIAGNOSTICSCHH2023-07-26
10673486001471Teco Diagnostics Cholesterol Reagent SetTECO DIAGNOSTICSCHH2023-07-26
10673486001402Teco Diagnostics Cholesterol (Liquid) Reagent SetTECO DIAGNOSTICSCHH2023-07-25
10673486001433Teco Diagnostics Cholesterol (Liquid) Reagent SetTECO DIAGNOSTICSCHH2023-07-25
10673486001440Teco Diagnostics Cholesterol TC MatrixTECO DIAGNOSTICSCHH2023-07-25
00816042014079FORAFORA CARE INC.CHH2023-06-26
80816042014174FORAFORA CARE INC.CHH2023-06-26
80816042014860FORAFORA CARE INC.CHH2023-06-26
00816042014161FORAFORA CARE INC.CHH2023-06-16
00887473000320STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.CHH2023-04-07
00887473000283STANDARD™ LipidoCare AnalyzerSD Biosensor, Inc.CHH2023-03-17