FDA.reportPublic FDA data

RealStar® ASR BKV Primer

Primary DI
04250453100802
Brand
RealStar® ASR BKV Primer
Company
altona Diagnostics GmbH
Model
031093-01
Device description
BK virus (BKV) 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
04250453100802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250453100802042504531008024250453100802

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
04250453100819RealStar® ASR BKV Probe031093-112020-02-24
04250453100826RealStar® ASR CMV Primer021093-012020-02-24
04250453100833RealStar® ASR CMV Probe021093-112020-02-24
04250453100840RealStar® ASR EBV Primer131093-012020-02-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382906718167HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718174HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718181HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718198HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718204HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718211HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718235HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718242HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718259HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718266HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718273HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718280HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718310HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718327HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718334HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718341HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718358Not ApplicableBecton, Dickinson And CompanyMVU2026-09-24
00382906718365HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718372HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718389HorizonBecton, Dickinson And CompanyMVU2026-09-24
00382906718396HorizonBecton, Dickinson And CompanyMVU2026-09-24
00840542202094Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202100Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202117Anti-Hepatitis B Virus Core Antigen (HBcAg)BIOGENEX LABORATORIESMVU2026-09-22
00840542202186Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202193Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202209Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202216Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202223Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22
00840542202230Anti-Herpes Simplex Virus Type II (HSV II)BIOGENEX LABORATORIESMVU2026-09-22