FDA UDI
In Commercial Distribution
🇺🇸 United States
RealTime
DI: 00884999037472
·
Model: 06L87-02
·
ABBOTT MOLECULAR INC.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RealTime
- Primary DI
- 00884999037472
- Version / Model
- 06L87-02
- Catalog Number
- 06L87-02
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c2f2c793-125f-4af5-a897-a64e9a2abfc5
Device Description
Uracil-N-Glycosylase (UNG)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| MZP | ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS | Microbiology | 866.3170 | 2 |
| LSL | DNA-REAGENTS, NEISSERIA | Microbiology | 866.3390 | 2 |
| OBF | Assay, genotyping, hepatitis c virus | Microbiology | 866.3170 | 2 |
| MZF | Test, hiv detection | Microbiology | 866.3956 | 2 |
| MKZ | DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA | Microbiology | 866.3120 | 1 |
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 | 00884999037472 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BP060002 | 000 |
| K080739 | 000 |
| P100017 | 000 |
| P120012 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius