FDA.reportPublic FDA data

Coagulase Cryo™

Primary DI
00819398026581
Brand
Coagulase Cryo™
Company
HARDY DIAGNOSTICS
Model
Z202
Catalog number
Z202
Device description
Coagulase Cryo™, frozen rabbit plasma for tube or slide coagulase test for Staphylococcus aureus detection, 0.5ml fill, 2ml vial, 20 per packageThe ready-to-use Coagulase Cryo is used to differentiate Staphylococcus species based on the ability to produce coagulase. It contains rabbit plasma, and is used to test for the production of free coagulase.The tube coagulase test is used to identify pathogenic staphylococci. The Staphylococcus species that are capable of producing coagulase include S. aureus (potentially pathogenic in humans and animals) and the animal isolates S. intermedius and S. hyicus.
Published
2020-08-06
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
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
00819398026581PrimaryGS10
00819398026574Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819398026581008193980265818193980265810819398026581
00819398026574008193980265748193980265740819398026574

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 Temperature-20 Degrees Celsius-2 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
039981550
Device count
20
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
00819398026574Coagulase Cryo™HARDY DIAGNOSTICSJTL2020-08-06
00816576028207CoaguStaph™HARDY DIAGNOSTICSJTL2020-06-25
00816576028221CoaguStaph™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