NA
Basic Information
- Brand Name
- NA
- Primary DI
- 00816576021840
- Version / Model
- DR900A
- Catalog Number
- DR900A
- Company Name
- HARDY DIAGNOSTICS
- Labeler DUNS
- 039981550
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2020-03-31
- Public Version Status
- Update
- Public Device Record Key
- 21108fe4-3b22-4971-96b9-d94682ab42e2
- Distribution End Date
- 2018-09-27
Device Description
MRSA-Screen consists of latex reagent sensitized with a monoclonal antibody against penici|lin—binding protein 2'(2a). or PBP2' (PBP2a), together with control latex and 2'extraction reagents to rapidly extract PBP2' from the bacterial cell membranes of MRSA. Extracts are prepared by boiling a suspension of S. aureus cells under alkaline conditions, followed by neutralization and a centrifugation step. The supernatant is subsequently mixed with the latex reagents on a test card and visible clumping or agglutination within three minutes with the sensitized latex but not the control latex confirms the presence of MRSA. MATERIALS SUPPLIED Sensitized Test Latex - (dropper bottle with pink cap) Latex particles are sensitized with a monoclonal antibody against PBP2'. Control Latex - (dropper bottle with a blue cap) Latex particles are sensitized with a monoclonal antibody of the same IgG subclass but against a human protein showing no reactivity with proteins of Staphylococcus aureus . Extraction Reagent 1 - (green cap) 0.1 mol/L NaOH Extraction Reagent 2 - (yellow cap) 0.5 mol/L KH 2 PO 4 Test Cards Mixing Sticks Package Insert
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| MYI | System,Test,Genotypic Detection,Resistant Markers,Staphylococcus Colonies | Microbiology | 866.1640 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51659 | Staphylococcus aureus culture isolate antigen IVD, kit, agglutination | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Staphylococcus aureus bacteria isolated by culture from a clinical specimen, using an agglutination method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816576021840 | GS1 |
Customer Contacts
- Phone
- 800-266-2222
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011400 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius