FDA UDI
In Commercial Distribution
🇺🇸 United States
PK7400 TP HA CONTROLS
DI: 05060515140047
·
Model: B11187
·
NEWMARKET BIOMEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PK7400 TP HA CONTROLS
- Primary DI
- 05060515140047
- Version / Model
- B11187
- Company Name
- NEWMARKET BIOMEDICAL LIMITED
- Labeler DUNS
- 217095816
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-14
- Public Version
- 1
- Public Version Date
- 2019-11-22
- Public Version Status
- New
- Public Device Record Key
- e724f39d-afc4-49ab-9b73-4abc9d838f60
Device Description
PK7400 TP HA CONTROLS is intended for use with the PK7400 TP HA REAGENT (B11186) for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies in human serum, EDTA plasma and CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| GMR | Sera, Reactive And Non-Specific Control, Fta-Abs Test | Microbiology | 866.3830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51817 | Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060515140047 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 16 x 5mL |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius