FDA.reportPublic FDA data

VIDAS® Serum Free

Primary DI
03573026551469
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

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

Regulatory Flags#

DUNS number
276816717
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03573026064532VIDAS® Measles IgG302192019-08-30
03573026064518VIDAS® Varicella-Zoster IgG302172016-08-31
03573026610418VITEK®MSVITEKMS SW v1.0 / FlexPrep v1.02019-04-30
03573026644796VIDAS® Varicella-Zoster IgG30217-012026-01-19
03573026550523ETEST® Tigecycline (TGC)Etest® TIGECYCLINE2016-12-12
03573026584139ID color CatalaseID color Catalase2019-07-19
03573026092009ID color CatalaseID color Catalase2019-07-19
03573026559823THxID™ BRAF1.02017-05-12
03573026121631VIDAS® Quality Control307062019-11-19
B0744000160ASTUTE140 Electronic Quality Control (EQC) Device4000164000162016-08-12
B0745000090NEPHROCHECK Calibration Verification (Cal Vers) Kit5000095000092016-08-12
B0745000110NEPHROCHECK Test Kit 5000115000112016-08-12
B0745000130NEPHROCHECK Liquid Control Kit5000135000132016-08-12
03573026547226ETEST® Ertapenem (ETP)ETEST® Ertapenem (ETP)2016-11-18
03573026547271ETEST® Tobramycin (TM)ETEST® Tobramycin (TM)2016-11-18
03573026547295ETEST® Tigecycline (TGC)ETEST® Tigecycline (TGC)2016-11-18
03573026548674ETEST® Ampicillin/sulbactam (2/1) (AB)ETEST® Ampicillin/sulbactam (2/1) (AB)2016-11-18
03573026549046ETEST® Tetracycline (TC)ETEST® Tetracycline (TC)2016-11-18
03573026549077ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)ETEST® Trimethoprim/sulfamethoxazole (1/19) (TS)2016-11-18
03573026547196ETEST® Fosfomycin (FM)ETEST® Fosfomycin (FM)2016-11-18

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
03573026097295VIDAS® Serum FreeBIOMERIEUX SAJFT2016-08-31
00380740016258ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06
00380740016265ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06
00380740016272ARCHITECTAbbott Ireland DiagnosticsJFT2016-06-06