FDA.reportPublic FDA data

RealStar® ASR EBV Primer

Primary DI
04250453100840
Brand
RealStar® ASR EBV Primer
Company
altona Diagnostics GmbH
Model
131093-01
Device description
Epstein-Barr virus (EBV) DNA specific primer
Published
2020-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04250453100840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250453100840042504531008404250453100840

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
312597593
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
04250453100055RealStar® ASR Trichomonas vaginalis Primer711093-012020-02-24
04250453100062RealStar® ASR Trichomonas vaginalis Probe711093-112020-02-24
04250453100802RealStar® ASR BKV Primer031093-012020-02-24
04250453100819RealStar® ASR BKV Probe031093-112020-02-24
04250453100826RealStar® ASR CMV Primer021093-012020-02-24
04250453100833RealStar® ASR CMV Probe021093-112020-02-24
04250453100857RealStar® ASR EBV Probe131093-112020-02-24
04250453100864RealStar® ASR Parvovirus B19 Primer101093-012020-02-24
04250453100871RealStar® ASR Parvovirus B19 Probe101093-112020-02-24
04250453100888RealStar® ASR Adenovirus Primer301093-012020-02-24
04250453100895RealStar® ASR Adenovirus Probe301093-112020-02-24
04250453100901RealStar® ASR HHV-6 Primer311093-012020-02-24
04250453100918RealStar® ASR HHV-6 Probe311093-112020-02-24
04250453100925RealStar® ASR HSV-1 Primer061093-012020-02-24
04250453100932RealStar® ASR HSV-1 Probe061093-112020-02-24
04250453100949RealStar® ASR HSV-2 Primer061093-022020-02-24
04250453100956RealStar® ASR HSV-2 Probe061093-122020-02-24
04250453100963RealStar® ASR VZV Primer071093-012020-02-24
04250453100970RealStar® ASR VZV Probe071093-112020-02-24
04250453100987RealStar® ASR JCV Primer041093-012020-02-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810227730204Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2026-07-13
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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
00810034704160APC anti-human CD64BIOLEGEND, INC.MVU2026-06-05
00810034704177FITC anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704191PE/Cyanine7 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704214APC anti-human CD31BIOLEGEND, INC.MVU2026-06-05
00810034704245APC anti-human CD274BIOLEGEND, INC.MVU2026-06-05
00810034704290APC/Fire™ 750 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034702951PerCP/Cyanine5.5 anti-human Beta2-microglobulinBIOLEGEND, INC.MVU2026-06-01
00810034704061PE/Dazzle™ 594 anti-human CD22BIOLEGEND, INC.MVU2026-06-01
00810034704092FITC anti-human CD35BIOLEGEND, INC.MVU2026-06-01
00810034704108PE/Cyanine7 anti-human CD22BIOLEGEND, INC.MVU2026-06-01
00810034704139PE/Cyanine7 anti-human CD300eBIOLEGEND, INC.MVU2026-06-01
08595715450544CyFlow™ CD200 PE-Cy7EXBIO Praha, a.s.MVU2025-10-01
00850051429219Fort Worth DiagnosticsFort Worth Diagnostics, LLCMVU2024-03-01
08719327450949Anti-HbF PUREIQ Products B.V.MVU2023-01-26
08719327450956Anti-HbF FITCIQ Products B.V.MVU2023-01-26
08719327450963Anti-HbF R-PEIQ Products B.V.MVU2023-01-26
08719327450970Anti-HbF Dy-410IQ Products B.V.MVU2023-01-26
08719327450987anti-HbS PUREIQ Products B.V.MVU2023-01-26
08719327450994anti-HbS FITCIQ Products B.V.MVU2023-01-26
08719327451014CD163 PURE IQ Products B.V.MVU2023-01-26
08719327451021CD163 FITCIQ Products B.V.MVU2023-01-26