FDA UDI
In Commercial Distribution
🇺🇸 United States
RealTime
DI: 00884999023918
·
Model: 06L18-66
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RealTime
- Primary DI
- 00884999023918
- Version / Model
- 06L18-66
- Catalog Number
- 06L18-66
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ebd72981-ad17-4186-b589-1b3ee2e41dbd
Device Description
Abbott RealTime HIV-1 Amplification Including Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HIV-1 assay List Number 06L18
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| MZF | Test, hiv detection | Microbiology | 866.3956 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61119 | DNA anti-contamination enzyme reagent IVD | A substance or reactant intended to be used as a hydrolyzing enzyme in a molecular assay to prevent contamination of the resulting deoxyribonucleic acid (DNA) amplicon, by preventing unintentional carry over of amplification products from a previous assay, in the analysis of a clinical laboratory specimen, using a polymerase chain reaction (PCR) technique. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999023918 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BP060002 | 13 |
| BP060002 | 14 |
| BP060002 | 16 |
| BP060002 | 18 |
| BP060002 | 21 |
| BP060002 | 22 |
| BP060002 | 25 |
| BP060002 | 26 |
| BP060002 | 27 |
| BP060002 | 28 |
| BP060002 | 29 |
| BP060002 | 36 |
| BP060002 | 37 |
| BP060002 | 38 |
| BP060002 | 42 |
| BP060002 | 45 |
| BP060002 | 46 |
| BP060002 | 48 |
| BP060002 | 6 |
| BP060002 | 8 |
| BP060002 | 9 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius