FDA UDI
In Commercial Distribution
🇺🇸 United States
CoaguStaph™
DI: 00816576028221
·
Model: Z003
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- CoaguStaph™
- Primary DI
- 00816576028221
- Version / Model
- Z003
- Catalog Number
- Z020
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2020-06-25
- Public Version
- 2
- Public Version Date
- 2020-09-03
- Public Version Status
- Update
- Public Device Record Key
- 27c76fd4-d078-4360-9af9-a0027703ffc7
Device Description
CoaguStaph™, Rabbit Coagulase Plasma with EDTA, freeze dried, coagulase test for Staphylococcus aureus, 6x20ml Lyophilized 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.
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 | 00816576028214 | GS1 | ||||
| Primary | 00816576028221 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius