RADI 192 Whole Blood DNA/RNA Extraction Kit

Primary DI
08800204300508
Brand
RADI 192 Whole Blood DNA/RNA Extraction Kit
Company
KH Medical Co., Ltd.
Model
OP003
Device description
This product is based on magnetic extraction method that separates nucleic acids using a silica-coated magnetic bead. The sample is first lysed by the provided Lysis buffer to expose the nucleic acid, and the exposed nucleic acid is binds to the Silica-coated magnetic bead, and impurities are removed by the washing buffer. After this, the purified DNA/RNA is eluted with an Elution buffer.
Published
2022-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800204300508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800204300508088002043005088800204300508

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695801965
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800204300690RADI PCR 96 PlusKM0052022-10-11
08800204300096RADI CHAMP260KM0022022-09-19
08800204300720RADI PREP PLUS 48 Universal DNA/RNA KitAP1102023-01-03
08800204300706RADI 32 Viral DNA/RNA Extraction KITOP0012022-11-17
08800204300010RADI PREP PlusKM0012022-09-19
08800204300027RADI Extractor 192OE0062022-09-19
08800204300034RADI 192 Viral DNA/RNA Extraction KitOP0022022-09-19
08800204300102RADI PREP Plus 48KM0032022-09-19
08800204300133RADI Extractor 32OE0052022-09-19
08800204300300RADI PREP PLUS Swab and Stool DNARNA KITAP0062022-09-19
08800204300515RADI 192 Tissue DNA/RNA Extraction KitOP0042022-09-19
08800204300522RADI 192 Bacteria DNA/RNA Extraction KitOP0052022-09-19
08800204300539RADI 48 Viral DNA/RNA Extraction kitAP1022022-09-19
08800204300546RADI PREP PLUS 48 Swab DNA,RNA Extraction KitAP1012022-09-19
08800204300553RADI 48 Whole Blood DNA/RNA Extraction KitAP1032022-09-19
08800204300560RADI 48 Tissue DNA Extraction KitAP1042022-09-19
08800204300577RADI 48 Bacteria DNA Extraction KitAP1052022-09-19
08800204300683RADI PREP PLUS Universal DNA/RNA KITAP0102022-09-19