FDA.report

caerGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit-N

Primary DI
08809446082029
Brand
caerGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kit-N
Company
WELLS BIO, INC.
Model
MHN-N00082
Catalog number
MHN-N00082
Published
2023-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JJHClinical Sample Concentrator

Product Code Classifications

CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809446082029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809446082029088094460820298809446082029

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
689849476
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08809446080841careGENE™ Viral/Pathogen HiFi Nucleic Acid Isolation kitMVP-N09683MVP-N096832022-11-11

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