FDA.reportPublic FDA data

CarboFerm™

Primary DI
00816576029068
Brand
CarboFerm™
Company
HARDY DIAGNOSTICS
Model
Z98
Catalog number
Z98
Device description
CarboFerm™ I, rapid carbohydrate test for Neisseria and Moraxella, 24 tests per kitFor the rapid identification and differentiation of Neisseria spp., including N. gonorrhoeae and N. meningitidis, and Moraxella (Branhamella) catarrhalis. CarboFerm™ uses acid production from carbohydrates to differentiate and identify Neisseria species and M. catarrhalis. Performs a glucose, lactose, maltose, sucrose, and butyrate test
Published
2020-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIBDevice, General Purpose, Microbiology, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIBDevice, General Purpose, Microbiology, DiagnosticMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576029068PrimaryGS10
00819398027632Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576029068008165760290688165760290680816576029068
00819398027632008193980276328193980276320819398027632

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Haemophilus/Neisseria bacteria species culture isolate identification IVD, kitA collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of bacteria belonging to the Haemophilus or Neisseria genera, that have been isolated by culture from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
24
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
30197344074369MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074376MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074383MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
30197344074390MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074362MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074379MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074386MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
20197344074393MEDLINEMEDLINE INDUSTRIES, INC.LIB2025-11-14
06973267011369RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011376FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012366RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012373FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267013349RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011345RIGID INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0102TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267011352FLEXIBLE INOCULATION LOOP,1UL,TUBE PACK,TYPENEX,LP0103TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012342RIGID INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0202TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267012359FLEXIBLE INOCULATION LOOP,10UL,TUBE PACK,TYPENEX,LP0203TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
06973267013332RIGID INOCULATION NEEDLE,TUBE PACK,TYPENEX,LP0302TBZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-07-17
05032384127993REAGENT SPOT INDOLE DMACAOXOID LIMITEDLIB2025-06-27
09555240404992SCU Narrow Cap SamplerITL ASIA PACIFIC SDN. BHD.LIB2025-06-04
19555240404999SCU Narrow Cap SamplerITL ASIA PACIFIC SDN. BHD.LIB2025-06-04
09555240405593SCU Narrow Cap Sampler Syringe KitITL ASIA PACIFIC SDN. BHD.LIB2025-04-21
19555240405590SCU Narrow Cap Sampler Syringe KitITL ASIA PACIFIC SDN. BHD.LIB2025-04-21
06973267011260Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011277Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012267Inoculating Loop 10ul rigid perforated bag packTypenex LP0202PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267012274Inoculating Loop 10ul flexible Typenex LP0203PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267013240Inoculating Needle Rigid perforated bag packTypenex LP0302PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011246Inoculating Loop 1ul rigid perforated bag pack Typenex, LP0102PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13
06973267011253Inoculating Loop 1ul flexible perforated bag packTypenex LP0103PFZHEJIANG RUNLAB TECHNOLOGY CO., LTDLIB2025-02-13