HardyDisk™

Primary DI
00816576028467
Brand
HardyDisk™
Company
HARDY DIAGNOSTICS
Model
Z7291
Catalog number
Z7291
Device description
Novobiocin 5ug, NB-5, 1 x 50 disks, for the identification of Staphylococcus saprophyticus Used to identify Staphylococcus saprophyticus, which is resistant to Novobiocin 5ug (zones less than or equal to 16mm).
Published
2020-08-10
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
JTODiscs, Strips And Reagents, Microorganism Differentiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTODiscs, Strips And Reagents, Microorganism DifferentiationMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576028474PrimaryGS10
00816576028467Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576028474008165760284748165760284740816576028474
00816576028467008165760284678165760284670816576028467

GMDN Terms#

Term, Definition table
TermDefinition
Novobiocin differentiation disc IVDOne or multiple diagnostic discs impregnated with the antimicrobial novobiocin intended to be used in microbial testing for the differentiation of coagulase-negative Staphylococcus species isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
50
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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00816576027439 QwikIDIG06020C03IG06020C032025-06-23
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00816576023516N/A102010202020-05-26
00816576025800TransPROTPV50TPV502024-10-08
00816576026951N/AG367G3672024-07-08
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