FDA.reportPublic FDA data

CoaguStaph™

Primary DI
00816576028221
Brand
CoaguStaph™
Company
HARDY DIAGNOSTICS
Model
Z003
Catalog number
Z020
Device description
CoaguStaph™, Rabbit Coagulase Plasma with EDTA, freeze dried, coagulase test for Staphylococcus aureus, 6x20mlLyophilized rabbit plasma, for the identification of Staphylococcus aureus by the coagulase test. EDTA helps eliminate false positives, not recommended for germ tubes, packaged in a vial with a rubber septum and aluminum crimp seal.
Published
2020-06-25
Public version status
Update
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
JTLPlasma, Coagulase, Human, Horse And Rabbit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTLPlasma, Coagulase, Human, Horse And RabbitMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816576028221PrimaryGS10
00816576028214Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816576028221008165760282218165760282210816576028221
00816576028214008165760282148165760282140816576028214

GMDN Terms#

Term, Definition table
TermDefinition
Coagulase production microbial reagent IVDA substance or reactant intended to be used in microbial testing to detect the enzyme coagulase, produced by a microorganism isolated from a clinical specimen by culture.

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
6
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
00848838022227REMELREMEL, INC.JTL2023-01-03
00848838022241REMELREMEL, INC.JTL2023-01-03
00848838022258REMELREMEL, INC.JTL2023-01-03
00848838022265REMELREMEL, INC.JTL2023-01-03
05060472467515Rabbit Coagulase Plasma (10x3ml)PRO-LAB, INCORPORATEDJTL2022-12-20
05060472467522Rabbit Coagulase Plasma (1x10ml)PRO-LAB, INCORPORATEDJTL2022-12-20
05060472467539Rabbit Coagulase Plasma (1x20ml)PRO-LAB, INCORPORATEDJTL2022-12-20
05060472467546Rabbit Coagulase Plasma (1x30ml)PRO-LAB, INCORPORATEDJTL2022-12-20
00819398026581Coagulase Cryo™HARDY DIAGNOSTICSJTL2020-08-06
00819398026574Coagulase Cryo™HARDY DIAGNOSTICSJTL2020-08-06
00816576028207CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
00816576028191CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
00816576028214CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
30382902406588BD BBL™ Coagulase Plasma, RabbitBECTON, DICKINSON AND COMPANYJTL2018-05-25
30382902406618BD BBL™ Coagulase Plasma, RabbitBECTON, DICKINSON AND COMPANYJTL2018-05-25
30382902408261BD BBL™ Coagulase Plasma, Rabbit with EDTABECTON, DICKINSON AND COMPANYJTL2018-05-25
30382902408278BD BBL™ Coagulase Plasma, Rabbit with EDTABECTON, DICKINSON AND COMPANYJTL2018-05-25