BIOBASE
- Primary DI
- 06971674867227
- Brand
- BIOBASE
- Company
- Biobase Biodustry(Shandong)Co., Ltd.
- Model
- R1:18mL×1 R2:6mL×1
- Published
- 2023-07-22
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| JZJ | Prealbumin, Antigen, Antiserum, Control |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| JZJ | Prealbumin, Antigen, Antiserum, Control | Immunology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06971674867227 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06971674867227 | 06971674867227 | 6971674867227 |
GMDN Terms
| Term | Definition |
|---|---|
| Prealbumin (transthyretin) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of prealbumin (transthyretin) in a clinical specimen. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 420046355
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06936895301882 | BIOBASE | R1:64mL×2 R2:16mL×2 | 2023-07-26 | |
| 06936895301899 | BIOBASE | R1:20mL×1 R2:5mL×1 | 2023-07-26 | |
| 06936895301905 | BIOBASE | R1:20mL×4 R2:5mL×4 | 2023-07-26 | |
| 06936895301912 | BIOBASE | R1:60mL×5 R2:15mL×5 | 2023-07-26 | |
| 06936895301929 | BIOBASE | R1:64mL×2 R2:16mL×2 | 2023-07-26 | |
| 06936895301936 | BIOBASE | R1:20mL×1 R2:5mL×1 | 2023-07-26 | |
| 06936895301943 | BIOBASE | R1:20mL×4 R2:5mL×4 | 2023-07-26 | |
| 06936895301950 | BIOBASE | R1:60mL×5 R2:15mL×5 | 2023-07-26 | |
| 06971674862932 | BIOBASE | R1:70mL×2 R2:14mL×2 | 2023-07-24 | |
| 06971674862949 | BIOBASE | R1:60mL×2 R2:12mL×2 | 2023-07-24 | |
| 06971674862956 | BIOBASE | R1:25mL×4 R2:5mL×4 | 2023-07-24 | |
| 06971674862963 | BIOBASE | R1:25mL×1 R2:5mL×1 | 2023-07-24 | |
| 06971674862970 | BIOBASE | R1:40mL×4 R2:16mL×2 | 2023-07-24 | |
| 06971674862987 | BIOBASE | R1:50mL×2 R2:10mL×2 | 2023-07-24 | |
| 06971674862994 | BIOBASE | R1:80mL×2 R2:16mL×2 | 2023-07-24 | |
| 06971674863007 | BIOBASE | R1:100mL×1 R2:20mL×1 | 2023-07-24 | |
| 06971674863014 | BIOBASE | R1:50mL×2 R2:20mL×1 | 2023-07-24 | |
| 06971674863021 | BIOBASE | R1:50mL×2 R2:20mL×1 | 2023-07-24 | |
| 06971674863038 | BIOBASE | R1:50mL×2 R2:10mL×2 | 2023-07-24 | |
| 06971674863045 | BIOBASE | R1:50mL×2 R2:10mL×2 | 2023-07-24 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00630414313412 | Atellica CH Prealbumin (PALB) | Siemens Healthcare Diagnostics Inc. | JZJ | 2024-02-02 |
| 06971674867203 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | JZJ | 2023-07-24 |
| 06971674867210 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | JZJ | 2023-07-24 |
| 06971674867258 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | JZJ | 2023-07-24 |
| 06971674867265 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | JZJ | 2023-07-24 |
| 06971674867968 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | JZJ | 2023-07-24 |
| 06971674867234 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | JZJ | 2023-07-22 |
| 06971674867241 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | JZJ | 2023-07-22 |
| 05055273204759 | PREALBUMIN (PreALB) | RANDOX LABORATORIES LIMITED | JZJ | 2022-10-05 |
| 00380740169947 | Alinity | ABBOTT IRELAND | JZJ | 2021-05-19 |
| 04015630913787 | Prealbumin - Application for C.f.a.s. PAC | Roche Diagnostics GmbH | JZJ | 2021-01-18 |
| 04015630928804 | Prealbumin | Roche Diagnostics GmbH | JZJ | 2021-01-18 |
| 00630414517704 | ADVIA® Chemistry PREALB Prealbumin Reagents | Siemens Healthcare Diagnostics Inc. | JZJ | 2020-09-24 |
| 00630414596259 | Atellica CH PreAlb | Siemens Healthcare Diagnostics Inc. | JZJ | 2020-09-24 |
| 00842768011399 | N Antiserum to Human Prealbumin | Siemens Healthcare Diagnostics Products GmbH | JZJ | 2020-09-24 |
| 00842768006210 | DImension Vista® Prealbumin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | JZJ | 2020-09-24 |
| 05700572000211 | Poly Rb A-Hu Prealbumin | Dako Denmark ApS | JZJ | 2020-09-17 |
| 03610230007396 | Yumizen C1200 Prealbumin | HORIBA ABX SAS | JZJ | 2020-08-31 |
| 10758750006908 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | JZJ | 2020-04-18 |
| 07613336147894 | Prealbumin | Roche Diagnostics GmbH | JZJ | 2020-03-05 |
| 00380740174897 | ARCHITECT | Abbott GmbH & Co. KG | JZJ | 2020-02-29 |
| 00380740150709 | Alinity | Abbott GmbH & Co. KG | JZJ | 2018-10-05 |
| 00380740000219 | ARCHITECT | ABBOTT LABORATORIES | JZJ | 2018-07-31 |
| 00380740009861 | ARCHITECT | ABBOTT LABORATORIES | JZJ | 2018-07-31 |
| B1761540 | Antiserum to Human Prealbumin | KENT LABORATORIES INC | JZJ | 2016-09-24 |
| B1761545 | Prealbumin RID plate kit | KENT LABORATORIES INC | JZJ | 2016-09-24 |
| 05051700010771 | Human Prealbumin BINDARID™ Radial Immunodiffusion | THE BINDING SITE GROUP LIMITED | JZJ | 2016-09-24 |
| 05051700016100 | Human Prealbumin Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | JZJ | 2016-09-24 |
| 05051700018135 | Optilite Prealbumin Kit | THE BINDING SITE GROUP LIMITED | JZJ | 2016-09-24 |
| 00816426020276 | K-ASSAY® Prealbumin Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | JZJ | 2016-09-16 |