FDA UDI
In Commercial Distribution
🇺🇸 United States
BRT Liquid Assayed Chemistry Control
DI: EABA10090101
·
Model: 100-9010
·
Bioresource Technology
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- BRT Liquid Assayed Chemistry Control
- Primary DI
- EABA10090101
- Version / Model
- 100-9010
- Catalog Number
- 100-9010
- Company Name
- Bioresource Technology
- Labeler DUNS
- 928908037
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2021-04-01
- Public Version
- 1
- Public Version Date
- 2021-04-09
- Public Version Status
- New
- Public Device Record Key
- a96673ae-02d9-44f6-8d3b-421f9199bea7
Device Description
BRT Chemistry Control is a human liquid assayed or control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert for the Abaxis Piccolo Express®.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47869 | Multiple-type clinical chemistry analyte profile IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | EABA10090100 | HIBCC | ||||
| Primary | EABA10090101 | HIBCC |