FDA UDI
In Commercial Distribution
🇺🇸 United States
Sure-Vue
DI: 00613647001592
·
Model: T3018-9002
·
FISHER SCIENTIFIC COMPANY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
9600
Basic Information
- Brand Name
- Sure-Vue
- Primary DI
- 00613647001592
- Version / Model
- T3018-9002
- Catalog Number
- 23038083
- Company Name
- FISHER SCIENTIFIC COMPANY L.L.C.
- Labeler DUNS
- 004321519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 9600
- Record Status
- Published
- Publish Date
- 2019-04-18
- Public Version
- 1
- Public Version Date
- 2019-04-26
- Public Version Status
- New
- Public Device Record Key
- b844f477-e2a2-494e-90ae-510fda689195
Device Description
Sure-Vue Signature Automated RPR 9,600 Test kit
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
- Yes
- 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 |
|---|---|---|---|---|
| GMP | ANTISERA, CONTROL FOR NONTREPONEMAL TESTS | Microbiology | 866.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51819 | Treponema pallidum reagin antibody IVD, kit, agglutination | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613647001592 | GS1 | ||||
| Unit of Use | 10613647001599 | GS1 |
Customer Contacts
- Phone
- +1(724)517-2425
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius