FDA UDI
In Commercial Distribution
🇺🇸 United States
Pediatric Bilirubin Control Level 2 Set 3x3mL
DI: 00896863002301
·
Model: 1332-31
·
QUANTIMETRIX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Pediatric Bilirubin Control Level 2 Set 3x3mL
- Primary DI
- 00896863002301
- Version / Model
- 1332-31
- Catalog Number
- 1332-31
- Company Name
- QUANTIMETRIX CORPORATION
- Labeler DUNS
- 010717890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-26
- Public Version
- 1
- Public Version Date
- 2018-10-29
- Public Version Status
- New
- Public Device Record Key
- 5223cfc0-2be6-4243-8416-39176e31999d
Device Description
The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin assay methods to validate quantitation of patient samples. It is supplied as a liquid, 3x3mL vials per box. It is prepared from purified bilirubin in a human protein base, stabilizers and preservatives have been added.
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30215 | Total bilirubin IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total bilirubin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00896863002301 | GS1 | ||||
| Secondary | M0511332311 | HIBCC |
Customer Contacts
- Phone
- (310) 536-0006
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K860942 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius