StrepQuick™
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,…
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
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Jiangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Zhejiang Runlab Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Record
| Listed by | Hardy Diagnostics, United States |
|---|---|
| FDA product code | LIB |
| Device type | Device, General Purpose, Microbiology, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Z122 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 45 |
| Caplugs/Evergreen | Caplugs, Inc. | 28 |
| Device, General Purpose, Microbiology, Diagnostic | Scientific Device Laboratory, Inc. | 21 |
| Globe Scientific | Globe Scientific, LLC | 20 |
| Medline | Medline Industries, Inc. | 15 |
| Parasite Suspensions | Microbiologics, Inc. | 12 |
| Inoculating Loop | Zhejiang Runlab Technology Co., Ltd. | 4 |
| Planet-Safe® | Diversified Biotech, Inc. | 4 |
| Device, General Purpose, Microbiology, Diagnostic | Hardy Diagnostics | 4 |
| Inoculating Loop Typenex | Zhejiang Runlab Technology Co., Ltd. | 4 |
| MicroScan | Beckman Coulter, Inc. | 3 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 2 |
Showing 12 of 64. All products under Device, General Purpose, Microbiology, Diagnostic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.