Discs, Strips and Reagents, Microorganism Differentiation
PYR Test Kit, with 15ml chromogenic solution and test cards, 25 cards that have 3 tests per card, total of 75 tests per kit Hardy Diagnostics PYR Test Kit and PYR Reagent are recommended…
PYR Test Kit, with 15ml chromogenic solution and test cards, 25 cards that have 3 tests per card, total of 75 tests per kit Hardy Diagnostics PYR Test Kit and PYR Reagent are recommended for the detection of pyrolidonyl arylamidase (also called pyrolidonyl aminopeptidase) activity in certain groups of bacteria, such as Streptococcus pyogenes (group A strep), Enterococcus spp., some coagulase-negative staphylococci, and some Enterobacteriaceae. The card format is easier to handle than disks. Three tests can be performed on one card. Contains: PYR Test Card (25) 00819398027144 PYR Chromagenic Solution 15mL (1) 00819398028660
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Jilin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Changchun LYZ Technology Co., Ltd. | Changchun | Jilin | Manufacturer | 16 |
| Zhejiang Joozena Medical Technology Co., Ltd. | Dongyang City, Jinhua | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Hardy Diagnostics, United States |
|---|---|
| FDA product code | JTO |
| Device type | Discs, Strips And Reagents, Microorganism Differentiation |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K961191 |
| Record published | 2020-06-16 |
| Record revised | 2023-04-28 (version 2) |
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 30 °C |
| Distribution end date | 2026-02-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Z67 | In distribution | ||
| Z65 | In distribution | ||
| Z62 | In distribution | ||
| Z175 | In distribution | ||
| Z262 | In distribution | ||
| Z124 | In distribution | ||
| Z173 | In distribution | ||
| Z68 | In distribution | ||
| Z91 | In distribution | ||
| Z92 | In distribution | ||
| Z77 | In distribution | ||
| Z125 | In distribution | ||
| Z19 | 20 | In distribution | |
| Z112 | 50 | In distribution | |
| Z63 | In distribution | ||
| Z61 | In distribution | ||
| Z76 | In distribution | ||
| Z18 | 20 | In distribution | |
| Z204 | 20 | In distribution | |
| Z71 | In distribution | ||
| Z117 | In distribution | ||
| Z72 | In distribution | ||
| Z275 | In distribution | ||
| Z119 | In distribution | ||
| Z111 | 25 | In distribution | |
| Z70 | In distribution | ||
| Z73 | In distribution | ||
| Z75 | In distribution | ||
| Z78 | In distribution | ||
| Z126 | In distribution | ||
| Z127 | In distribution | ||
| Z52 | 20 | Withdrawn | |
| Z135 | Withdrawn | ||
| Z51 | 20 | Withdrawn | |
| Z15 | Withdrawn | ||
| Z134 | Withdrawn | ||
| Z206 | 20 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 62 |
| HardyDisk™ | Hardy Diagnostics | 17 |
| Bactidrop | Remel, Inc. | 10 |
| Redipor | Analytichem USA, Inc. | 7 |
| BD BBL™ Taxo™ P | Becton, Dickinson AND Company | 4 |
| BD BBL™ Taxo™ A | Becton, Dickinson AND Company | 4 |
| API® NaCl 0.85% Medium | bioMerieux, Inc. | 3 |
| Bacticard | Remel, Inc. | 3 |
| Chemmette Reagents | Microbiologics, Inc. | 2 |
| Optochin | Oxoid, Ltd. | 2 |
| X Factor | Oxoid, Ltd. | 2 |
| X & V Factor | Oxoid, Ltd. | 2 |
Showing 12 of 139. All products under Discs, Strips And Reagents, Microorganism Differentiation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K961191 | 1996-06-17 |
| K960996 | 1996-04-18 |
| K931865 | 1993-12-15 |
| K931862 | 1993-06-15 |
| K931414 | 1993-05-12 |
| K930693 | 1993-05-12 |
| K931413 | 1993-05-11 |
| K930717 | 1993-04-23 |
| K930718 | 1993-04-23 |
| K930720 | 1993-04-23 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2003-12-31 | Not classified | Other | Mislabeled. | 39 bottles of Z71 and 6 bottles of Z72 | 2004-05-17 |
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.