FDA.reportPublic FDA data

Bordetella immunology reagents IgA

Primary DI
07290013348487
Brand
Bordetella immunology reagents IgA
Company
SAVYON DIAGNOSTICS LTD
Model
2233-01
Catalog number
2233-01
Device description
Bordetella immunology reagents IgA- IgA Sera pack
Published
2023-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290013348487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290013348487072900133484877290013348487

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

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
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
07290013348470Conjugate IgMFA232-12MFA232-12M2023-06-29
07290016332193Serum Diluent IgMFB262-03MFB262-03M2023-06-29
07290016332636Bordetella Pertussis IgGA2231-01MA2231-01M2023-06-16
07290013348494Bordetella immunology reagents IgM2232-012232-012023-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810227730211Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429820Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429837Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429844Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00850051429851Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-24
00810227730006Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730013Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730020Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730037Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429967Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429974Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429981Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00850051429998Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-22
00810227730044Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730051Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730068Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730136Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730143Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730150Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
00810227730228Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-21
05055844935792CytoCell myProbesCYTOCELL LIMITEDMVU2026-07-19
00810227730198Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810227730204Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
00810034704306Spark Violet™ 538 anti-human CD4BIOLEGEND, INC.MVU2026-07-06
00810034704337Spark Violet™ 423 anti-human CD45BIOLEGEND, INC.MVU2026-07-06
15099590807160Anti-TCR Cß1 (TRBC1)-FITCIMMUNOTECHMVU2026-06-25
05055844935761CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
05055844935778CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
00810034704085FITC anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704146PE/Cyanine7 anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05