StrepPRO™
Basic Information
- Brand Name
- StrepPRO™
- Primary DI
- 00819398027984
- Version / Model
- PL030HD
- Catalog Number
- PL030HD
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-02
- Public Version
- 1
- Public Version Date
- 2020-09-10
- Public Version Status
- New
- Public Device Record Key
- 87d3ec3a-574a-45ac-ac9d-72bf717241a4
Device Description
StrepPRO™ Streptococcal Grouping Kit, rapid latex agglutination test for Streptococcus Lancefield grouping, 60 tests A unique streptococcal grouping latex agglutination kit for the rapid identification of group A, B, C, D, F, and G Streptococcus from culture. Each kit contains: * PL031HD Blue Latex Suspension Group A, 3ml 1 vial/kit (00819398027854) * PL032HD Blue Latex Suspension Group B, 3ml 1 vial/kit (00819398027861) * PL033HD Blue Latex Suspension Group C, 3ml 1 vial/kit (00819398027878) * PL034HD Blue Latex Suspension Group D, 3ml 1 vial/kit (00819398027885) * PL035HD Blue Latex Suspension Group F, 3ml 1 vial/kit (00819398027892) * PL036HD Blue Latex Suspension Group G, 3ml 1 vial/kit (00819398027908) * PL037HD Extraction Reagent 1, 3.5ml 1 vial/kit (00819398027915) * PL038HD Extraction Reagent 2, 3.5ml 1 vial/kit (00819398027922) * PL039HD Extraction Reagent 3, 8.5ml 2 vials/kit (00819398027939) * PL040HD Polyvalent Positive Control, 3.5ml 1 vial/kit (00819398027946) * PL092HD Latex Test Cards 48 cards/kit (00819398027977) * Mixing Sticks 300 sticks/kit (00819398027960)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | Microbiology | 866.3740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43730 | Beta-haemolytic Streptococcus serological grouping IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay used to determine the serological group (or Lancefield group) of beta-haemolytic streptococci isolated from a clinical specimen by culture. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00819398027984 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius