FDA UDI
In Commercial Distribution
🇺🇸 United States
StatusFirst Mono controls
DI: 10743816001010
·
Model: BSP-402C-00
·
PRINCETON BIOMEDITECH CORPORATION
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- StatusFirst Mono controls
- Primary DI
- 10743816001010
- Version / Model
- BSP-402C-00
- Catalog Number
- BSP-402C-00
- Company Name
- PRINCETON BIOMEDITECH CORPORATION
- Labeler DUNS
- 362917692
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 45b89de2-551f-48f4-bd4c-ddc13eb61d15
Device Description
StatusFirst Mono Pos/Neg controls (2 x 1 mL)
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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 49691 | Epstein-Barr virus (EBV) heterophile 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 heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10743816001010 | GS1 |
Customer Contacts
- Phone
- 8005262125
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius