FDA.reportPublic FDA data

Serum Diluent IgM

Primary DI
07290016332193
Brand
Serum Diluent IgM
Company
SAVYON DIAGNOSTICS LTD
Model
FB262-03M
Catalog number
FB262-03M
Device description
Serum Diluent IgM
Published
2023-06-29
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
PPMGeneral Purpose Reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPMGeneral Purpose ReagentPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016332193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016332193072900163321937290016332193

GMDN Terms#

Term, Definition table
TermDefinition
Enzyme immunoassay (EIA) generic reagent kit IVDA collection of general reagents and other associated materials intended to be used to perform an enzyme immunoassay on clinical specimens; it is not dedicated to the detection of any one type of analyte. It typically consists of an enzyme conjugate, blocking buffer, wash buffer and a substrate solution.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533708202
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
07290006418326CHROMOSTREAKBD-915BD-9152026-05-27
07290006418111DIASLIDE URINE CULTURING DEVICEDS-1052026-05-04
07290013348531URISCREEN 101-012026-04-29
17290006558937Feminine Screening KitF-1-VO-CVS022026-02-22
07290006558930Feminine Screening KitF-1-VO-CVS022026-02-22
07290001913147SeroELISA Chlamydia IgGA111-01A111-012025-05-29
07290001913161SeroELISA Chlamydia IgAA113-012025-05-29
07290013348302Conjugate IgAFA233-12MFA233-12M2023-06-29
07290013348470Conjugate IgMFA232-12MFA232-12M2023-06-29
07290016332636Bordetella Pertussis IgGA2231-01MA2231-01M2023-06-16
07290013348487Bordetella immunology reagents IgA2233-012233-012023-06-29
07290013348494Bordetella immunology reagents IgM2232-012232-012023-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405012305Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012312Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012329Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012411Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012428Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012435Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012459Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012466Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012473Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012497Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012503Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012510Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012527Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012534Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012541Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012558Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012565Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405012589Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405013432Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014163Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014170Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405014200Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016730Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405016778Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405017133Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405017140Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023219Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023271Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023356Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08
00846405023363Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-08