Home GUDID 05713106994627 Dermatophyte and C. albicans Real Time PCR kit
Primary DI 05713106994627
Brand Dermatophyte and C. albicans Real Time PCR kit
Company Ssi Diagnostica A/S
Model 99462
Catalog number 99462
Device description Intended useThe Dermatophyte and C. albicans Real Time PCR Kit is an in vitro diagnostic kit for the quantitative detection of general dermatophytes (pan-dermatophytes), Trichophyton (T.) rubrum and Candida (C.) albicans in nail, skin, and hair specimens.
Published 2022-11-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name JSR Kit, Identification, Dermatophyte
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JSR Kit, Identification, Dermatophyte Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05713106994627 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05713106994627 05713106994627 5713106994627
GMDN Terms# Term, Definition table Term Definition Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple dermatophyte species, which may include M. canis, M. audouinii, T. rubrum and T. violaceum in a clinical specimen, using a nucleic acid technique (NAT).
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Stored at a dark place at -20 Degrees Celsius
Regulatory Flags# DUNS number 305684449 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 DI Brand Model Catalog Published 05713106850046 E. coli O8 serum, 1 mL 85004 85004 2021-08-11 05713106850053 E. coli O9 serum, 1 mL 85005 85005 2021-08-11 05713106850237 E. coli O26 serum, 1 mL 85023 85023 2021-08-11 05713106850428 E. coli O45 serum, 1 mL 85042 85042 2021-08-11 05713106850831 E. coli O88 serum, 1 mL 85083 85083 2021-08-11 05713106850978 E. coli O103 serum, 1 mL 85097 85097 2021-08-11 05713106850985 E. coli O104 serum, 1 mL 85098 85098 2021-08-11 05713106851074 E. coli O111 serum, 1 mL 85107 85107 2021-08-11 05713106851180 E. coli O121 serum, 1 mL 85118 85118 2021-08-11 05713106851357 E. coli O139 serum, 1 mL 85135 85135 2021-08-11 05713106851371 E. coli O141 serum, 1 mL 85137 85137 2021-08-11 05713106851418 E. coli O145 serum, 1 mL 85141 85141 2021-08-11 05713106851456 E. coli O149 serum, 1 mL 85145 85145 2021-08-11 05713106851531 E. coli O157 serum, 1 mL 85153 85153 2021-08-11 05713106457405 E. coli O1 serum, 3 mL 45740 45740 2021-08-02 05713106457412 E. coli O2 serum, 3 mL 45741 45741 2021-08-02 05713106457443 E. coli O5 serum, 3 mL 45744 45744 2021-08-02 05713106457450 E. coli O6 serum, 3 mL 45745 45745 2021-08-02 05713106457948 E. coli O55 serum, 3 mL 45794 45794 2021-08-02 05713106458150 E. coli O78 serum, 3 mL 45815 45815 2021-08-02
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