Home GUDID 04719872780878 NA
Primary DI 04719872780878
Brand NA
Company PHARMIGENE, Inc.
Model PG-B27A-024
Device description The PG27 Detection Reagent is used for amplification of the HLA-B*27 allele.
Published 2023-06-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name MVU Reagents, Specific, Analyte
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MVU Reagents, Specific, Analyte Pathology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04719872780878 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04719872780878 04719872780878 4719872780878
GMDN Terms# Term, Definition table Term Definition Ankylosing spondylitis IVD, primer A defined piece of single-stranded nucleic acid which binds to and initiates replication of a target nucleic acid template in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inherited genetic condition ankylosing spondylitis which is associated with the HLA-B27 allele and/or other genetic markers including polymorphisms of the CYP2D6 gene or IL-1 gene complex.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -25 Degrees Celsius -15 Degrees Celsius
Regulatory Flags# DUNS number 658637223 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05055844935761 CytoCell myProbes CYTOCELL LIMITED MVU 2026-06-06 05055844935778 CytoCell myProbes CYTOCELL LIMITED MVU 2026-06-06 00810034704085 FITC anti-human Granzyme B BIOLEGEND, INC. MVU 2026-06-05 00810034704146 PE/Cyanine7 anti-human Granzyme B BIOLEGEND, INC. MVU 2026-06-05 00810034704160 APC anti-human CD64 BIOLEGEND, INC. MVU 2026-06-05 00810034704177 FITC anti-human CD69 BIOLEGEND, INC. MVU 2026-06-05 00810034704191 PE/Cyanine7 anti-human CD69 BIOLEGEND, INC. MVU 2026-06-05 00810034704214 APC anti-human CD31 BIOLEGEND, INC. MVU 2026-06-05 00810034704245 APC anti-human CD274 BIOLEGEND, INC. MVU 2026-06-05 00810034704290 APC/Fire™ 750 anti-human CD69 BIOLEGEND, INC. MVU 2026-06-05 00810034702951 PerCP/Cyanine5.5 anti-human Beta2-microglobulin BIOLEGEND, INC. MVU 2026-06-01 00810034704061 PE/Dazzle™ 594 anti-human CD22 BIOLEGEND, INC. MVU 2026-06-01 00810034704092 FITC anti-human CD35 BIOLEGEND, INC. MVU 2026-06-01 00810034704108 PE/Cyanine7 anti-human CD22 BIOLEGEND, INC. MVU 2026-06-01 00810034704139 PE/Cyanine7 anti-human CD300e BIOLEGEND, INC. MVU 2026-06-01 08595715450544 CyFlow™ CD200 PE-Cy7 EXBIO Praha, a.s. MVU 2025-10-01 08719327450949 Anti-HbF PURE IQ Products B.V. MVU 2023-01-26 08719327450956 Anti-HbF FITC IQ Products B.V. MVU 2023-01-26 08719327450963 Anti-HbF R-PE IQ Products B.V. MVU 2023-01-26 08719327450970 Anti-HbF Dy-410 IQ Products B.V. MVU 2023-01-26 08719327450987 anti-HbS PURE IQ Products B.V. MVU 2023-01-26 08719327450994 anti-HbS FITC IQ Products B.V. MVU 2023-01-26 08719327451014 CD163 PURE IQ Products B.V. MVU 2023-01-26 08719327451021 CD163 FITC IQ Products B.V. MVU 2023-01-26 08719327451038 CD163 R-PE IQ Products B.V. MVU 2023-01-26 08719327451045 CD163 Biotin IQ Products B.V. MVU 2023-01-26 08719327451052 CD64 PURE IQ Products B.V. MVU 2023-01-26 08719327451069 CD64 CyQ IQ Products B.V. MVU 2023-01-26 08719327451076 CD64 FITC IQ Products B.V. MVU 2023-01-26 08719327451083 CD64 R-PE IQ Products B.V. MVU 2023-01-26
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