BIOBASE
- Primary DI
- 06971674863304
- Brand
- BIOBASE
- Company
- Biobase Biodustry(Shandong)Co., Ltd.
- Model
- R1:48mL×2 R2:12mL×2
- Published
- 2023-07-21
- 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 |
|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | Clinical Chemistry | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06971674863304 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06971674863304 | 06971674863304 | 6971674863304 |
GMDN Terms
| Term | Definition |
|---|---|
| Total lactate dehydrogenase (LDH) 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 total lactate dehydrogenase (LDH) 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 |
|---|---|---|---|---|
| 00380740155322 | Alinity | ABBOTT IRELAND | CFJ | 2025-12-19 |
| 00380740155339 | Alinity | ABBOTT IRELAND | CFJ | 2025-12-19 |
| 00380740195236 | ARCHITECT | ABBOTT IRELAND | CFJ | 2025-12-19 |
| 00380740195243 | ARCHITECT | ABBOTT IRELAND | CFJ | 2025-12-19 |
| 00850053916137 | IDG/Sanzay | IDG/SANZAY Corporation | CFJ | 2024-01-12 |
| 10673486002027 | Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix | TECO DIAGNOSTICS | CFJ | 2023-11-13 |
| 10673486002034 | Teco Diagnostics Lactate Dehydrogenase (LDH-L) Liquid Reagent Set | TECO DIAGNOSTICS | CFJ | 2023-11-13 |
| 10673486002041 | Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix | TECO DIAGNOSTICS | CFJ | 2023-11-13 |
| 10673486002058 | Teco Diagnostics LDH Liquid Reagent Kit for TC Matrix | TECO DIAGNOSTICS | CFJ | 2023-11-13 |
| 10673486002065 | Teco Diagnostics LDH-L Reagent Set | TECO DIAGNOSTICS | CFJ | 2023-11-13 |
| 10673486002072 | Teco Diagnostics LDH-L Reagent Set | TECO DIAGNOSTICS | CFJ | 2023-11-13 |
| 06971674863267 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863274 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863281 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863298 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863311 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863328 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863335 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863342 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863359 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863366 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863373 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 06971674863380 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | CFJ | 2023-07-21 |
| 00811727015891 | Pointe Lactate Reagent | POINTE SCIENTIFIC, INC. | CFJ | 2021-01-30 |
| 00811727015907 | Pointe Lactate Dehydrogenase Reagent | POINTE SCIENTIFIC, INC. | CFJ | 2021-01-30 |
| 00811727016195 | Pointe Lactic Acid Reagent | POINTE SCIENTIFIC, INC. | CFJ | 2021-01-30 |
| 00811727016201 | Pointe Lactate Dehydrogenase Reagent | POINTE SCIENTIFIC, INC. | CFJ | 2021-01-30 |
| 03610230007075 | Yumizen C1200 LDH | HORIBA ABX SAS | CFJ | 2020-08-28 |
| 10758750031108 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | CFJ | 2020-04-18 |
| 07613336121368 | Lactate Dehydrogenase acc. to IFCC ver.2 | Roche Diagnostics GmbH | CFJ | 2020-03-05 |