VIDAS® Serum Free

Primary DI
03573026097295
Brand
VIDAS® Serum Free
Company
BIOMERIEUX SA
Model
VIDAS® Serum Free
Device description
The Serum free reagent can be used with VIDAS ® assays for which its use is clearly indicated in the VIDAS assay package insert.
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JFTFluorometric, Cortisol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFTFluorometric, CortisolClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931031000VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENTBiomerieux Vitek, Inc.1993-07-27JFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03573026097295PackageGS12In Commercial Distribution
03573026551469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03573026097295035730260972953573026097295
03573026551469035730265514693573026551469

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVDA buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
276816717
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336180778Elecsys Cortisol IIIRoche Diagnostics GmbHJFT2025-07-24
00630414598666Atellica IM Cor MCMSiemens Healthcare Diagnostics Inc.JFT2020-09-24
00630414293608Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2020-05-31
00630414294155Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2020-05-31
00380740130053AlinityAbbott Ireland DiagnosticsJFT2018-08-10
00380740130060AlinityAbbott Ireland DiagnosticsJFT2018-08-10
04015630939985Elecsys Cortisol IIRoche Diagnostics GmbHJFT2018-06-06
00630414598642Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2018-02-06
00630414598659Atellica IM CorSiemens Healthcare Diagnostics Inc.JFT2018-02-06
00630414598673Atellica Cort Urine Recon BufferSiemens Healthcare Diagnostics Inc.JFT2018-02-06
14560189210735ST AIA-PACK CORTTOSOH CORPORATIONJFT2016-09-24
04560189211698AIA-PACK CORT Calibrator SetTOSOH CORPORATIONJFT2016-09-24
04560189211704AIA-PACK CORT Sample Diluting SolutionTOSOH CORPORATIONJFT2016-09-24
00630414121819ADVIA Centaur Cortisol Urine Reconstitution BufferSiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414524610ADVIA Centaur® COR +ESiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414524740ADVIA Centaur® COR MCMSiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414602943ADVIA Centaur® CORSiemens Healthcare Diagnostics Inc.JFT2016-09-24
00630414602950ADVIA Centaur® COR +ESiemens Healthcare Diagnostics Inc.JFT2016-09-24
04015630940677Elecsys Cortisol IIRoche Diagnostics GmbHJFT2016-09-20
03573026551469VIDAS® Serum FreeBIOMERIEUX SAJFT2016-08-31
00380740016258ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06
00380740016265ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06
00380740016272ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06