FDA.reportPublic FDA data

Conjugate IgM

Primary DI
07290013348470
Brand
Conjugate IgM
Company
SAVYON DIAGNOSTICS LTD
Model
FA232-12M
Catalog number
FA232-12M
Device description
Conjugate 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
07290013348470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290013348470072900133484707290013348470

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
17290006558081VS-SENSE OTCF-1-VOCS-022023-06-27
17290006558098VagiVital VSF-1-VO-VVUS-022023-06-28
17290006558135Feminine Screening KitF-1-VO-CVS022023-06-28
17290006558166VS-SENSEF-VS-HS22023-06-28
17290006558173NuvetestF-1-VS-EX2023-06-28
07290013348074SeroMP IgAA263-01A263-012026-06-23
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
07290016332193Serum Diluent IgMFB262-03MFB262-03M2023-06-29
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
05407013460206mRNA Buffer 103 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460213mRNA Buffer 103 : 200L BagLonza VerviersPPM2026-09-24
05407013460237mRNA Buffer 112 : 200L BagLonza VerviersPPM2026-09-24
05407013460244mRNA Buffer 112 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460251mRNA Buffer 113 : 1L Bag sampleLonza VerviersPPM2026-09-24
05407013460268mRNA Buffer 113 : 200L BagLonza VerviersPPM2026-09-24
05407013460282Bulk Packaged ster. filtered WFI - 1LLonza VerviersPPM2026-09-24
04015630967162ISH Peroxidase InhibitorVentana Medical Systems, Inc.PPM2026-07-13
04049016151272FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151289Biotin-labelled anti-human IgGEUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151296FITC-labelled Avidin (biotin affine)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
04049016151630FITC-labelled anti-human IgG (primate absorbed)EUROIMMUN Medizinische Labordiagnostika AGPPM2026-06-10
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00846405023417Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-06-09
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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