FDA UDI
In Commercial Distribution
🇺🇸 United States
Coagulase Cryo™
DI: 00819398026581
·
Model: Z202
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Coagulase Cryo™
- Primary DI
- 00819398026581
- Version / Model
- Z202
- Catalog Number
- Z202
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2020-08-06
- Public Version
- 1
- Public Version Date
- 2020-08-14
- Public Version Status
- New
- Public Device Record Key
- 292c50f1-6fae-41d0-9fab-6c2e003c5608
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
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | Microbiology | 866.2160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00819398026574 | GS1 | ||||
| Primary | 00819398026581 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – -2 Degrees Celsius