N/A

Primary DI
00816576024575
Brand
N/A
Company
HARDY DIAGNOSTICS
Model
R64BX
Catalog number
R64BX
Device description
Viral Transport Medium, 3ml, order by 100/ boxFor 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
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816576020058NAE31E312016-09-01
00816576024995N/AG123G1232020-05-18
00816576026968N/AG367G3672024-07-08
00816576027965N/AW95W952020-06-08
00819398028653N/AZ206Z2062020-08-06
00816576027958N/AW95W952020-06-08
00816576024858N/AG105G1052020-05-18
00819398024600N/AY100Y1002020-06-08
00819398024808N/AY110Y1102020-06-09
00819398024907N/AY115Y1152020-06-09
00819398024594N/AY100Y1002020-06-08
00819398023610N/AR76BXR76BX2020-06-05
00819398024242HardyFlask™X26X262020-06-08
00819398025102N/AY130Y1302020-06-09
00819398023603N/AR76BXR76BX2020-06-05
00819398024235HardyFlask™X26X262020-06-08
00819398022118N/AL22L222020-06-03
00819398025560N/AY310Y3102020-06-09
00819398028264N/AMV1MV12020-06-04
00816576027194HardyDisk™Z9495Z94952025-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975025173852BabioJinan Babio Biotechnology Co., Ltd.QMC2023-02-14
06975025173814BabioJinan Babio Biotechnology Co., Ltd.QMC2023-02-02
06973471960699Biosci™Shenzhen Dakewe Bio-engineering Co., LtdQMC2022-12-08
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
00816576024537N/AHARDY DIAGNOSTICSQMC2022-01-25