Identity
- Trade Name
- CoaguStaph™ FDA UDI
- Generic Name
- Coagulase production microbial reagent IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Z003 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- Z020 FDA UDI
- Primary DI / UDI-DI
- 00816576028221 FDA UDI
- FDA Product Code
- JTL FDA UDI
- GMDN Term
- Coagulase production microbial reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulase production microbial reagent IVD
CoaguStaph™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulase production microbial reagent IVD.
- Rabbit Coagulase Plasma (1x10ml) — PRO-LAB, INCORPORATED · Class I
- Rabbit Coagulase Plasma (1x20ml) — PRO-LAB, INCORPORATED · Class I
- Rabbit Coagulase Plasma (10x3ml) — PRO-LAB, INCORPORATED · Class I
- Rabbit Coagulase Plasma (1x30ml) — PRO-LAB, INCORPORATED · Class I
- CoaguStaph™ — HARDY DIAGNOSTICS · Class I
- Coagulase Cryo™ — HARDY DIAGNOSTICS · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI 27c76fd4-d078-4360-9af9-a0027703ffc7 36 fields · synced Jun 8, 2026