ARCHITECT
- Primary DI
- 00380740161583
- Brand
- ARCHITECT
- Company
- Abbott GmbH & Co. KG
- Model
- 3L82-22
- Catalog number
- 03L8222
- Device description
- Glucose
- Published
- 2020-01-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| CFR | HEXOKINASE, GLUCOSE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| CFR | Hexokinase, Glucose | Clinical Chemistry | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00380740161583 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00380740161583 | 00380740161583 | 380740161583 | 0380740161583 |
GMDN Terms
| Term | Definition |
|---|
| Glucose IVD, kit, enzyme spectrophotometry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an enzyme spectrophotometry method. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius | |
Regulatory Flags
- DUNS number
- 315786293
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- 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
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00850053916113 | IDG/Sanzay | IDG/SANZAY Corporation | CFR | 2024-06-25 |
| 10673486001693 | Teco Diagnostics Glucose (Hexokinase) Reagent Set | TECO DIAGNOSTICS | CFR | 2023-11-10 |
| 10673486001709 | Teco Diagnostics Glucose (Hexokinase) Reagent Set | TECO DIAGNOSTICS | CFR | 2023-11-10 |
| 10673486001662 | Teco Diagnostics Glucose (Hexokinase) Liquid Reagent | TECO DIAGNOSTICS | CFR | 2023-11-09 |
| 10673486001686 | Teco Diagnostics Glucose Hexokinase (Liquid) Reagent Kit for TC-Matrix | TECO DIAGNOSTICS | CFR | 2023-11-09 |
| 07613336161791 | Glucose HK Gen. 3 | Roche Diagnostics GmbH | CFR | 2022-11-18 |
| 00811727016157 | Pointe Glucose Reagent | POINTE SCIENTIFIC, INC. | CFR | 2021-01-30 |
| 00811727015846 | Pointe Glucose Hexokinase for BS480 | POINTE SCIENTIFIC, INC. | CFR | 2020-05-28 |
| 03610230007013 | Yumizen C1200 Glucose HK | HORIBA ABX SAS | CFR | 2020-05-06 |
| 03610230007020 | Yumizen C1200 Glucose HK | HORIBA ABX SAS | CFR | 2020-05-06 |
| 07613336121283 | Glucose HK | Roche Diagnostics GmbH | CFR | 2020-03-05 |
| 00380740161590 | ARCHITECT | Abbott GmbH & Co. KG | CFR | 2020-01-04 |
| 00817238011148 | Glucose UV REAGENT | CLINIQA CORPORATION | CFR | 2018-08-23 |
| 00380740135447 | Alinity | Abbott GmbH & Co. KG | CFR | 2018-07-11 |
| 00380740135454 | Alinity | Abbott GmbH & Co. KG | CFR | 2018-07-11 |
| 00852169008140 | ClearChem Diagnostics Inc. Glucose | CLEARCHEM DIAGNOSTICS INC. | CFR | 2018-04-30 |
| 00630414596488 | Atellica CH GluH_3 | Siemens Healthcare Diagnostics Inc. | CFR | 2017-12-22 |
| 00817302023169 | CLC480 Chemistry Analyzer W/ISE | CAROLINA LIQUID CHEMISTRIES CORPORATION | CFR | 2016-12-19 |
| 00817302022995 | CAROLINA LIQUID CHEMISTRIES CORP.® GLU REAGENT PRODUCT NO. DT208 | CAROLINA LIQUID CHEMISTRIES CORPORATION | CFR | 2016-10-17 |
| 00812137011985 | Glucose Reagent | CLINICAL DIAGNOSTIC SOLUTIONS, INC. | CFR | 2016-10-12 |
| 15099590010195 | AU | Beckman Coulter, Inc. | CFR | 2016-09-24 |
| 15099590020101 | AU | Beckman Coulter, Inc. | CFR | 2016-09-24 |
| 15099590060084 | AU | Beckman Coulter, Inc. | CFR | 2016-09-24 |
| 00842768005541 | Dimension® Flex® reagent cartridge GLUC | Siemens Healthcare Diagnostics Inc. | CFR | 2016-09-24 |
| 00842768015663 | Dimension Vista® Flex® reagent cartridge GLU | Siemens Healthcare Diagnostics Inc. | CFR | 2016-09-24 |
| 00857969006129 | ACE | ALFA WASSERMANN, INC. | CFR | 2016-09-24 |
| 00630414526812 | ADVIA® Chemistry GLUH_3 Glucose Hexokinase_3 Reagents | Siemens Healthcare Diagnostics Inc. | CFR | 2016-09-24 |
| 00630414561899 | ADVIA® Chemistry GLUH_c Glucose Hexokinase_3 Reagents, Concentrated | Siemens Healthcare Diagnostics Inc. | CFR | 2016-09-24 |
| 00657498000809 | Glucose Liqui-UV® | STANBIO LABORATORY, L.P. | CFR | 2016-09-23 |
| 00657498001615 | Sirrus® Glucose Liqui-UV® | STANBIO LABORATORY, L.P. | CFR | 2016-09-23 |
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