FDA UDI
In Commercial Distribution
🇺🇸 United States
ViroSeq
DI: 00884999007468
·
Model: 4J94-92
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ViroSeq
- Primary DI
- 00884999007468
- Version / Model
- 4J94-92
- Catalog Number
- 4J94-92
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-20
- Public Version
- 4
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- 6fe93742-709b-4d2c-b524-82c565d520ca
Device Description
Sequencing Consumables Kit
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PPM | General purpose reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61296 | Microplate IVD | A plate with multiple wells designed to contain small volumes of clinical specimens, reagents, or other materials for testing procedures performed by a laboratory analyser. It is typically made of sterilizable plastic material (e.g., polypropylene) and is used with manual or automated analysers. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884999007468 | GS1 |
Customer Contacts
- Phone
- +1(800)553-7042
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius