BIOBASE
- Primary DI
- 06971674866763
- Brand
- BIOBASE
- Company
- Biobase Biodustry(Shandong)Co., Ltd.
- Model
- R1:18mL×4 R2:6mL×4
- 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 |
|---|---|
| KHP | Acid, Lactic, Enzymatic Method |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| KHP | Acid, Lactic, Enzymatic Method | Clinical Chemistry | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06971674866763 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06971674866763 | 06971674866763 | 6971674866763 |
GMDN Terms
| Term | Definition |
|---|---|
| Lactate 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 qualitative and/or quantitative detection of lactate 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 |
|---|---|---|---|---|
| 80816042014549 | FORA | FORA CARE INC. | KHP | 2025-05-06 |
| 00850014861407 | HeartsCare LACTATE TEST STRIPS (10PCS/BOX) | Hearts Bio, Inc. | KHP | 2024-07-08 |
| 00850014861537 | HeartsCare LACTATE TEST STRIPS (25PCS/BOX) | Hearts Bio, Inc. | KHP | 2024-07-08 |
| 00380740158392 | ARCHITECT | ABBOTT IRELAND | KHP | 2024-01-24 |
| 00380740158408 | Alinity | ABBOTT IRELAND | KHP | 2024-01-24 |
| 00816042014505 | FORA | FORA CARE INC. | KHP | 2023-10-31 |
| 00850014861360 | HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX) | Hearts Bio, Inc. | KHP | 2023-08-08 |
| 06971674866756 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | KHP | 2023-07-22 |
| 06971674866770 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | KHP | 2023-07-22 |
| 00630414305066 | Atellica CH Lactate_3 | Siemens Healthcare Diagnostics Inc. | KHP | 2023-05-10 |
| 04015630918911 | Lactate Gen.2 | Roche Diagnostics GmbH | KHP | 2021-01-18 |
| 04015630925148 | Lactate Gen.2 | Roche Diagnostics GmbH | KHP | 2021-01-18 |
| 04015630926954 | Lactate Gen.2 | Roche Diagnostics GmbH | KHP | 2021-01-18 |
| 04713648766530 | THE EDGE Blood Lactate Monitoring System | APEX BIOTECHNOLOGY CORP. | KHP | 2021-01-18 |
| 04713648766547 | THE EDGE Blood Lactate Test Strip (non-sterile) | APEX BIOTECHNOLOGY CORP. | KHP | 2021-01-18 |
| 04713648766554 | THE EDGE Lactate Control Solution | APEX BIOTECHNOLOGY CORP. | KHP | 2021-01-18 |
| 00054749005505 | i-STAT | ABBOTT POINT OF CARE INC. | KHP | 2020-10-05 |
| 00842768005398 | Dimension® Flex® reagent cartridge LA | Siemens Healthcare Diagnostics Inc. | KHP | 2020-09-24 |
| 00842768015243 | Dimension Vista® Flex® reagent cartridge LA | Siemens Healthcare Diagnostics Inc. | KHP | 2020-09-24 |
| 03610230007068 | Yumizen C1200 Lactate | HORIBA ABX SAS | KHP | 2020-09-09 |
| 00380740179199 | Alinity | Abbott GmbH | KHP | 2020-08-28 |
| 00630414287270 | Atellica CH Lactate_2 (Lac_2) | Siemens Healthcare Diagnostics Inc. | KHP | 2020-08-19 |
| 00630414606095 | epoc NXS Host | Epocal Inc | KHP | 2020-06-18 |
| 10758750004454 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | KHP | 2020-04-18 |
| 10758750004911 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | KHP | 2020-04-18 |
| 07613336121351 | Lactate Gen.2 | Roche Diagnostics GmbH | KHP | 2020-03-05 |
| 05055273204070 | L-LACTATE (LAC) | RANDOX LABORATORIES LIMITED | KHP | 2019-06-03 |
| 05055273204094 | L-LACTATE (LAC) | RANDOX LABORATORIES LIMITED | KHP | 2019-06-03 |
| 05700699440570 | S4970 Rinse 1 Solution for 600mL, for ABL7xx | Radiometer Medical ApS | KHP | 2018-09-21 |
| 05700699441263 | Cleaning Solution with additive S8375 REF 944-126 | Radiometer Medical ApS | KHP | 2018-09-21 |