AccessGUDID - DEVICE: Coagulase Cryo™ (00819398026581)

GUDID

Device Identifier (DI) Information

Brand Name: Coagulase Cryo™
Version or Model: Z202
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z202
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398026581
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Coagulase Cryo™, frozen rabbit plasma for tube or slide coagulase test for Staphylococcus aureus detection, 0.5ml fill, 2ml vial, 20 per package The 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42737	Coagulase production microbial reagent IVD	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTL	Plasma, Coagulase, Human, Horse And Rabbit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and -2 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 292c50f1-6fae-41d0-9fab-6c2e003c5608
Public Version Date: August 14, 2020
Public Version Number: 1
DI Record Publish Date: August 06, 2020