FDA UDI
In Commercial Distribution
🇺🇸 United States
Lumipulse Infectious Diseases Controls
DI: 04987270235584
·
Model: 235584
·
FUJIREBIO INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Lumipulse Infectious Diseases Controls
- Primary DI
- 04987270235584
- Version / Model
- 235584
- Company Name
- FUJIREBIO INC.
- Labeler DUNS
- 710873907
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-31
- Public Version
- 2
- Public Version Date
- 2025-10-06
- Public Version Status
- Update
- Public Device Record Key
- df5013da-09f7-4a4b-8dbb-75fbc41209bf
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
- 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 |
|---|---|---|---|---|
| OHQ | Multi-Analyte Controls Unassayed | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42652 | Multiple blood-borne virus antigen/antibody IVD, control | A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of antigens and/or antibodies from one or multiple blood-borne viruses, in a clinical specimen. Viruses intended to be detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus and human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04987270235584 | GS1 |
Customer Contacts
- Phone
- 610-240-3800
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Number of bottles per kit = 8 | ||
| Device Size Text, specify | Total mLs per bottle = 3/3/2.5 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 10 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Right side up with care; no vibration