Diazyme
- Primary DI
- 00817089020610
- Brand
- Diazyme
- Company
- DIAZYME LABORATORIES, INC.
- Model
- DZ147A-K
- Published
- 2016-11-03
- 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 |
|---|---|
| K123785 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00817089020610 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00817089020610 | 00817089020610 | 817089020610 | 0817089020610 |
GMDN Terms#
| Term | Definition |
|---|---|
| Myoglobin IVD, kit, nephelometry/turbidimetry | A collection of reagents and other associated materials intended to be used for the quantitative measurement of myoglobin in a clinical specimen, using a nephelometry/turbidimetry method. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 080507219
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00817089022690 | Diazyme | DZ558A-KY1 | 2020-07-29 | |
| 00817089020900 | Diazyme Procalcitonin Assay | DZ558A-K | 2017-09-01 | |
| 00817089022478 | Diazyme | DZ248A-CON | 2026-01-21 | |
| 00817089023048 | Diazyme | DZ122A-KY1 | 2026-01-21 | |
| 00817089023222 | Diazyme | 100148B-CAL | 2026-01-21 | |
| 00817089023239 | Diazyme | 100148B-CON | 2026-01-21 | |
| 00817089021358 | Diazyme | DZ168C-CAL | 2020-07-21 | |
| 00817089021365 | Diazyme | DZ168C-CON | 2020-07-21 | |
| 00817089021464 | Diazyme | DZ568A-CA5 | 2020-07-21 | |
| 00817089020047 | Diazyme | DZ122A-CAL | 2016-11-03 | |
| 00817089020054 | Diazyme | DZ122A-CON | 2016-11-03 | |
| 00817089020504 | Diazyme | DZ042A-CAL | 2016-11-03 | |
| 00817089020511 | Diazyme | DZ042A-CON | 2016-11-03 | |
| 00817089020535 | Diazyme | DZ179A-CAL | 2016-11-03 | |
| 00817089020542 | Diazyme | DZ179A-CON | 2016-11-03 | |
| 00817089020627 | Diazyme | DZ147A-CAL | 2016-11-03 | |
| 00817089020634 | Diazyme | DZ147A-CON | 2016-11-03 | |
| 00817089020689 | Diazyme | DZ768A-CAL | 2016-11-03 | |
| 00817089020696 | Diazyme | DZ768A-CON | 2016-11-03 | |
| 00817089020863 | Diazyme | DZ141A-CAL | 2016-11-03 |
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 |
| 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 |
| B176131 | Antiserum to Human Myoglobin | KENT LABORATORIES INC | 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 |