D-100 2901007
GUDID 00847817025693
D-100 Prefilter
BIO-RAD LABORATORIES, INC.
Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent Glycated haemoglobin (HbA1c) IVD, reagent| Primary Device ID | 00847817025693 |
| NIH Device Record Key | b0561383-f098-4376-9724-44e155b41caa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D-100 |
| Version Model Number | 290-1007 |
| Catalog Number | 2901007 |
| Company DUNS | 132528295 |
| Company Name | BIO-RAD LABORATORIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com | |
| Phone | +1(800)224-6723 |
| diagcs@bio-rad.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847817025693 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151321
FDA Product Code
| PDJ | Hemoglobin A1c test system |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-01-23 |
| Device Publish Date | 2016-09-12 |
On-Brand Devices [D-100]
| 00847817025693 | D-100 Prefilter |
| 00847817025679 | D-100 HbA1c Elution Buffer A |
| 00847817020155 | D-100 HbA1c Calibrator Pack |
| 00847817016035 | D-100 Wash Solution |
| 00847817016028 | D-100 HbA1c Elution Buffer B |
| 00847817016004 | D-100 Sample Diluent |
| 00847817015991 | D-100 Cleaning Tube |
| 00847817015953 | D-100 HbA1c Analytical Cartridge/Calibrator Pack |
Trademark Results [D-100]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 D-100 85850614 4993699 Live/Registered |
Bio-Rad Laboratories, Inc. 2013-02-14 |
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