IRON (Fe)
- Primary DI
- 05055273209433
- Brand
- IRON (Fe)
- Company
- RANDOX LABORATORIES LIMITED
- Model
- SI8330
- Published
- 2019-06-03
- 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 |
|---|---|
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | Clinical Chemistry | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05055273209433 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05055273209433 | 05055273209433 | 5055273209433 |
GMDN Terms
| Term | Definition |
|---|---|
| Iron IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of iron in a clinical specimen, using a spectrophotometry method. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 227530649
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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
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|---|---|---|---|---|
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| 05055273218985 | ConcizuTrace™ ELISA | CZM10591 | CZM10591 | 2025-05-30 |
| 05055273210101 | Liquid Immunoassay Control – Level 1 (IA CONTROL 1) | LIA5142 | LIA5142 | 2025-03-24 |
| 05055273210118 | LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2) | LIA5143 | LIA5143 | 2025-03-24 |
| 05055273210125 | LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3) | LIA5144 | LIA5144 | 2025-03-24 |
| 05055273219814 | PTH CONTROL LEVEL 1 (PTH CONTROL 1) | PTH10608 | PTH10608 | 2025-03-24 |
| 05055273219821 | PTH CONTROL LEVEL 2 (PTH CONTROL 2) | PTH10609 | PTH10609 | 2025-03-24 |
| 05055273219838 | PTH CONTROL LEVEL 3 (PTH CONTROL 3) | PTH10610 | PTH10610 | 2025-03-24 |
| 05055273219043 | LIQUID CARDIAC CONTROL 1 | CQ10534 | CQ10534 | 2025-03-21 |
| 05055273219050 | LIQUID CARDIAC CONTROL 2 | CQ10535 | CQ10535 | 2025-03-21 |
| 05055273219067 | LIQUID CARDIAC CONTROL 3 | CQ10536 | CQ10536 | 2025-03-21 |
| 05055273219128 | LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1) | CQ10616 | CQ10616 | 2025-03-21 |
| 05055273219135 | LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2) | CQ10617 | CQ10617 | 2025-03-21 |
| 05055273219142 | LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3) | CQ10618 | CQ10618 | 2025-03-21 |
| 05055273219159 | Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1) | LAL10565 | LAL10565 | 2025-03-21 |
| 05055273219166 | Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2) | LAN10566 | 2025-03-21 |
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| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
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| 10673486001983 | Teco Diagnostics Iron/TIBC Reagent Set | TECO DIAGNOSTICS | JMO | 2023-11-13 |
| 06971674869603 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | JMO | 2023-07-24 |
| 06971674869610 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | JMO | 2023-07-24 |
| 06971674869627 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | JMO | 2023-07-24 |
| 05055273209488 | TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) | RANDOX LABORATORIES LIMITED | JMO | 2022-09-23 |
| 05055273214727 | TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) | RANDOX LABORATORIES LIMITED | JMO | 2022-09-23 |
| 05055273214734 | TOTAL IRON-BINDING CAPACITY 2 (TIBC_2) | RANDOX LABORATORIES LIMITED | JMO | 2022-09-23 |
| 00811727015969 | Pointe Direct TIBC Reagent | POINTE SCIENTIFIC, INC. | JMO | 2021-01-30 |
| 00811727016263 | Pointe TIBC Reagent | POINTE SCIENTIFIC, INC. | JMO | 2021-01-30 |
| 00630414474748 | ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents | Siemens Healthcare Diagnostics Inc. | JMO | 2020-09-24 |
| 00630414595535 | Atellica CH TIBC | Siemens Healthcare Diagnostics Inc. | JMO | 2020-09-24 |
| 00842768005756 | Dimension® Flex® reagent cartridge IBCT | Siemens Healthcare Diagnostics Inc. | JMO | 2020-09-24 |
| 00842768015465 | Dimension Vista® Flex® reagent cartridge TIBC | Siemens Healthcare Diagnostics Inc. | JMO | 2020-09-24 |
| 10758750001873 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | JMO | 2020-04-18 |
| 07613336121597 | Unsaturated Iron-Binding Capacity | Roche Diagnostics GmbH | JMO | 2020-03-05 |
| 05055273206517 | TOTAL-IRON BINDING CAPACITY (TIBC) | RANDOX LABORATORIES LIMITED | JMO | 2019-06-03 |
| 05055273209426 | IRON (Fe) | RANDOX LABORATORIES LIMITED | JMO | 2019-06-03 |
| 05055273209495 | TOTAL-IRON BINDING CAPACITY (TIBC) | RANDOX LABORATORIES LIMITED | JMO | 2019-06-03 |
| 00816426021396 | K-ASSAY® UIBC Reagent | KAMIYA BIOMEDICAL COMPANY, LLC | JMO | 2019-04-09 |
| 00816426021402 | K-ASSAY® UIBC Reagent (L) | KAMIYA BIOMEDICAL COMPANY, LLC | JMO | 2019-04-09 |
| 00816426021419 | K-ASSAY® UIBC Calibrator | KAMIYA BIOMEDICAL COMPANY, LLC | JMO | 2019-04-09 |
| 00386100002190 | Iron (Fe) Reagent Kit | MEDICA CORPORATION | JMO | 2019-02-14 |
| 00852169008232 | ClearChem Diagnostics Inc. TIBC-Direct | CLEARCHEM DIAGNOSTICS INC. | JMO | 2018-05-22 |
| 00857969006020 | ACE | ALFA WASSERMANN, INC. | JMO | 2017-10-10 |
| 05060500091965 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | JMO | 2017-02-28 |
| 00817302022704 | CAROLINA LIQUID CHEMISTRIES CORP.® UIBC UNSATURATED IRON BINDING CAPACITY CC660 | CAROLINA LIQUID CHEMISTRIES CORPORATION | JMO | 2016-12-12 |
| 00817439021267 | Direct TIBC Reagent | Medtest Dx, Inc. | JMO | 2016-09-27 |
| 15099590011925 | AU | Beckman Coulter, Inc. | JMO | 2016-09-24 |
| 05060500091439 | Synermed® | INFRARED LABORATORY SYSTEMS LLC | JMO | 2016-09-20 |