Identity
- Trade Name
- StrepQuick™ FDA UDI
- Generic Name
- Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit FDA UDI
- Device Name
- StrepQuick™, to aid in the identification of gram positive cocci, performs a PYR, LAP, and Esculin test StrepQuick™ test kit is intended to aid in the identification of gram-positive, catalase-negative cocci based on pyroglutamate aminopeptidase (PYR), leucine aminopeptidase (LAP), and esculin hydrolysis (ESC) activity. This test kit simplifies identification of Enterococcus spp. and group A streptococci (Streptococcus pyogenes) Contains: StrepQuick Test Card (25) 00819398027274 Developer Reagent (1) 00819398028585 FDA UDI
- Model / Reference
- Z122 FDA UDI
- Description
- StrepQuick™, to aid in the identification of gram positive cocci, performs a PYR, LAP, and Esculin test StrepQuick™ test kit is intended to aid in the identification of gram-positive, catalase-negative cocci based on pyroglutamate aminopeptidase (PYR), leucine aminopeptidase (LAP), and esculin hydrolysis (ESC) activity. This test kit simplifies identification of Enterococcus spp. and group A streptococci (Streptococcus pyogenes) Contains: StrepQuick Test Card (25) 00819398027274 Developer Reagent (1) 00819398028585 FDA UDI
Identifiers
- Catalog Number
- Z122 FDA UDI
- Primary DI / UDI-DI
- 00819398028615 FDA UDI
- FDA Product Code
- LIB FDA UDI
- GMDN Term
- Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
Yes
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: Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
StrepQuick™ by Hardy Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 ae2db26b-91aa-43b0-b9f0-06c145a87e07 36 fields · synced May 30, 2026