FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00819398027502
·
Model: Z127
·
HARDY DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00819398027502
- Version / Model
- Z127
- Catalog Number
- Z127
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-10
- Public Version
- 1
- Public Version Date
- 2020-06-18
- Public Version Status
- New
- Public Device Record Key
- 07e355a1-2d42-4793-9e69-b03985e2c94d
Device Description
PYR Reagent, 15ml, dropper bottle, cinnamaldehyde For use in conjunction with PYR disks for the detection of pyroglutamate aminopeptidase found in group A streptococci (Streptococcus pyogenes) and group D enterococci. The PYR Reagent combines with beta-naphthyl amide released during pyroglutamate aminopeptidase (PYR) activity to form a pink to red pigment. See Z75 for the complete kit.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35998 | Pyrrolidonyl arylamidase (PYR) microbial reagent IVD | A substance or reactant intended to be used in microbial testing for the detection of pyrrolidonyl arylamidase (PYR) production and/or activity, for the presumptive identification of beta-haemolytic Streptococcus (Lancefield) group A and Enterococcus species (Lancefield) group D bacteria, activity in a clinical specimen and/or culture isolate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819398027502 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius