Antiserum to Human Myoglobin
- Primary DI
- B176131
- Brand
- Antiserum to Human Myoglobin
- Company
- KENT LABORATORIES INC
- Model
- 1
- Catalog number
- 131002
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| DDR | Myoglobin, Antigen, Antiserum, Control |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DDR | Myoglobin, Antigen, Antiserum, Control | Immunology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K771242 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B176131 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Myoglobin IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of myoglobin in a clinical specimen. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 093642254
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B1761250 | Antiserum to Human Transferrin | 1 | 125002 | 2016-09-24 |
| B1761254 | Transferrin RID plate package | 1 | 125411 | 2016-09-24 |
| B1761255 | Transferrin RID plate kit | 1 | 125511 | 2016-09-24 |
| B1761080 | Antiserum to Human Properdin | 1 | 108002 | 2016-09-24 |
| B1761082 | Anti Human Properdin FITC | 1 | 108202 | 2016-09-24 |
| B1761210 | Antiserum to Human C-3b Inactivator (factor I) | 1 | 121002 | 2016-09-24 |
| B1761212 | Anti Human C3b Inactivator FITC | 1 | 121202 | 2016-09-24 |
| B1761230 | Antiserum to Human Alpha 1 Acid Glycoprotein | 1 | 123002 | 2016-09-24 |
| B1761500 | Antiserum to Apolipoprotein A-1 | 1 | 150002 | 2016-09-24 |
| B1761520 | Antiserum to Apolipprotein B | 1 | 152002 | 2016-09-24 |
| B1761540 | Antiserum to Human Prealbumin | 1 | 154002 | 2016-09-24 |
| B1761000 | Antiserum to Whole Human Serum | 1 | 100002 | 2016-09-24 |
| B1761010 | Antiserum to Human IgG (gamma chain specific) | 1 | 101002 | 2016-09-24 |
| B1761011 | Rhodamine conjugated antiserum to Human IgG | 1 | 101102 | 2016-09-24 |
| B1761012 | Anti Human IgG FITC | 1 | 101202 | 2016-09-21 |
| B1761014 | IgG RID Plate Package | 1 | 101411 | 2016-09-24 |
| B1761015 | IgG RID Plate Kit | 1 | 101511 | 2016-09-24 |
| B1761018 | Peroxidase conjugated Antiserum to Human IgG | 1 | 101872 | 2016-09-24 |
| B1761020 | Antiserum to Human IgA (alpha chain specific) | 1 | 102002 | 2016-09-24 |
| B1761021 | Rhodamine conjugated antiserum to Human IgA | 1 | 1021002 | 2016-09-24 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07613336147863 | Tina-quant Myoglobin Gen.2 | Roche Diagnostics GmbH | DDR | 2020-08-21 |
| 00630414285047 | N Latex Myoglobin | Siemens Healthcare Diagnostics Products GmbH | DDR | 2020-05-29 |
| 00380740174910 | Alinity | Abbott Ireland Diagnostics | DDR | 2019-10-09 |
| 00380740174903 | Alinity | Abbott Ireland Diagnostics | DDR | 2019-07-08 |
| 00895160002496 | Fluoro-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION | DDR | 2019-05-24 |
| 30014613337157 | Triage | QUIDEL CARDIOVASCULAR INC. | DDR | 2018-11-01 |
| 30014613337164 | Triage | QUIDEL CARDIOVASCULAR INC. | DDR | 2018-11-01 |
| 30014613337911 | Triage | QUIDEL CARDIOVASCULAR INC. | DDR | 2018-11-01 |
| 30014613337959 | Triage | QUIDEL CARDIOVASCULAR INC. | DDR | 2018-11-01 |
| 00630414598468 | Atellica IM Calibrator U | Siemens Healthcare Diagnostics Inc. | DDR | 2018-02-06 |
| 00630414599663 | Atellica IM MYO | Siemens Healthcare Diagnostics Inc. | DDR | 2018-02-06 |
| 00630414599670 | Atellica IM MYO | Siemens Healthcare Diagnostics Inc. | DDR | 2018-02-06 |
| 00630414599687 | Atellica IM MYO MCM | Siemens Healthcare Diagnostics Inc. | DDR | 2018-02-06 |
| 04015630940059 | Elecsys Myoglobin | Roche Diagnostics GmbH | DDR | 2017-04-21 |
| 04015630939541 | CalSet Myoglobin | Roche Diagnostics GmbH | DDR | 2017-04-17 |
| 00817089020610 | Diazyme | DIAZYME LABORATORIES, INC. | DDR | 2016-11-03 |
| 00817089020627 | Diazyme | DIAZYME LABORATORIES, INC. | DDR | 2016-11-03 |
| 00817089020634 | Diazyme | DIAZYME LABORATORIES, INC. | DDR | 2016-11-03 |
| 00895160002458 | Nano-CheckTM 4 in 1 Test | NANO-DITECH CORPORATION | DDR | 2016-10-03 |
| 00899722002719 | Alere Triage® | Alere San Diego, Inc. | DDR | 2016-09-26 |
| 00899722002740 | Alere Triage® | Alere San Diego, Inc. | DDR | 2016-09-26 |
| 14560189210094 | ST AIA-PACK Myoglobin | TOSOH CORPORATION | DDR | 2016-09-24 |
| 04560189211018 | ST AIA-PACK Myoglobin CALIBRATOR SET | TOSOH CORPORATION | DDR | 2016-09-24 |
| 04560189211025 | ST AIA-PACK Myoglobin SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | DDR | 2016-09-24 |
| 05055273204681 | MYO CAL SET | RANDOX LABORATORIES LIMITED | DDR | 2016-09-24 |
| 00842768004490 | Stratus® CS Acute Care™ CKMB TestPak | Siemens Healthcare Diagnostics Inc. | DDR | 2016-09-24 |
| 00842768004506 | Stratus® CS Acute Care™ CKMB CalPak | Siemens Healthcare Diagnostics Inc. | DDR | 2016-09-24 |
| 00842768004513 | Stratus® CS Acute Care™ CKMB DilPak | Siemens Healthcare Diagnostics Inc. | DDR | 2016-09-24 |
| 00842768004520 | Stratus® CS Acute Care™ cTNI TestPak | Siemens Healthcare Diagnostics Inc. | DDR | 2016-09-24 |
| 00842768004537 | Stratus® CS Acute Care™ cTNI CalPak | Siemens Healthcare Diagnostics Inc. | DDR | 2016-09-24 |