Identity
- Trade Name
- Coagulase Cryo™ FDA UDI
- Generic Name
- Coagulase production microbial reagent IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Z202 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- Z202 FDA UDI
- Primary DI / UDI-DI
- 00819398026581 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
Coagulase Cryo™ 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.
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- Rabbit Coagulase Plasma (10x3ml) — PRO-LAB, INCORPORATED · Class I
- Rabbit Coagulase Plasma (1x30ml) — PRO-LAB, INCORPORATED · Class I
- CoaguStaph™ — HARDY DIAGNOSTICS · Class I
- CoaguStaph™ — 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 292c50f1-6fae-41d0-9fab-6c2e003c5608 36 fields · synced Jun 8, 2026