N/A

Primary DI
00816576024537
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
R64BX
Catalog number
R64BX
Device description
Viral Transport Medium, 3ml, order by 100/ box For the collection and transport of specimens to the lab for the recovery/identification of viruses. Refrigerate after inoculation. For long term storage after inoculation, freeze at -70C. Do not moisten swab with the media prior to use. Refer to the IFU.
Published
2022-01-25
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QMCTransport Medium, Notified Per The Vtm Guidance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QMCTransport Medium, Notified Per The Vtm GuidanceMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576024575PrimaryGS10
00816576024537Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576024575008165760245758165760245750816576024575
00816576024537008165760245378165760245370816576024537

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-266-2222techservice@hardydiagnostics.com

Regulatory Flags#

DUNS number
039981550
Device count
100
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

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00819398024808N/AY110Y1102020-06-09
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00819398024235HardyFlask™X26X262020-06-08
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975025173814BabioJinan Babio Biotechnology Co., Ltd.QMC2023-02-02
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06973471960712Biosci™Shenzhen Dakewe Bio-engineering Co., LtdQMC2022-12-08
06973471960729SNT BiotechShenzhen Dakewe Bio-engineering Co., LtdQMC2022-12-08
06973471960736SNT BiotechShenzhen Dakewe Bio-engineering Co., LtdQMC2022-12-08
06973471960705Biosci™Shenzhen Dakewe Bio-engineering Co., LtdQMC2022-12-08
00816576024575N/AHARDY DIAGNOSTICSQMC2022-01-25