Home GUDID 04719872780014 NA
Primary DI 04719872780014
Brand NA
Company PHARMIGENE, Inc.
Model PG-IC01A-024
Device description The PGIC01 Detection Reagent is used for amplification of an internal control gene.
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 04719872780014 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04719872780014 04719872780014 4719872780014
GMDN Terms# Term, Definition table Term Definition Killer cell immunoglobulin-like receptor (KIR) genotype/HLA ligand detection 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 one or multiple polymorphisms associated with killer cell immunoglobulin-like receptors (KIR) and/or their HLA associated ligands. KIR genotypes detected may include but are not limited to KIR2DL4, KIR3DL2, and KIR3DP1, associated with immune responses e.g., graft versus host disease, autoimmune disease and acute organ rejection.
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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