IMMCO DIAGNOSTICS 2310
GUDID 00845714002793
Stop Solution
IMMCO DIAGNOSTICS, INC.
Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00845714002793 |
| NIH Device Record Key | 8574037e-dc75-42b2-989e-7a89a4f1005b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMMCO DIAGNOSTICS |
| Version Model Number | 2310 |
| Catalog Number | 2310 |
| Company DUNS | 079935300 |
| Company Name | IMMCO DIAGNOSTICS, 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM | |
| Phone | 1-800-537-8378 |
| INFO@IMMCO.COM |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845714002793 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030701
FDA Product Code
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [IMMCO DIAGNOSTICS]
| 00845714004391 | Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit |
| 00845714004384 | Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit |
| 00845714004353 | Serum Diluent |
| 00845714004339 | Buffer Diluent |
| 00845714004322 | Buffer Diluent |
| 00845714004315 | Serum Diluent |
| 00845714004308 | Phosphate Buffered Saline |
| 00845714004247 | WASH BUFFER |
| 00845714004193 | Coverslips |
| 00845714004179 | Mounting Medium |
| 00845714004162 | Mounting Medium |
| 00845714004001 | cANCA Positive Control |
| 00845714003974 | ARA Positive Control |
| 00845714003967 | EMA (IgG) Positive Control |
| 00845714003943 | EMA Positive Control |
| 00845714003851 | pANCA Positive Control |
| 00845714003776 | cANCA Slide ethanol fixed |
| 00845714003769 | cANCA Slide |
| 00845714003752 | cANCA Slide |
| 00845714003714 | Pemphigold Positive |
| 00845714003707 | Pemphigus Foliaceus Control |
| 00845714003677 | nDNA Positive Control |
| 00845714003660 | Pemphigus Vulgaris Positive Control |
| 00845714003653 | Rat Kidney Slide |
| 00845714003646 | Primate Smooth Muscle Slide |
| 00845714003608 | Primate Esophagus (Distal) Slide |
| 00845714003592 | Primate Esophagus (Distal) Slide |
| 00845714003585 | Primate Esophagus Slide |
| 00845714003578 | Primate Esophagus (Distal) Slide |
| 00845714003561 | Primate Esophagus Slide |
| 00845714003554 | Primate/Guinea Pig Esophagus Slide |
| 00845714003547 | Mouse Kidney/Stomach/Liver Slide |
| 00845714003530 | Hep-2 Cells Slide |
| 00845714003479 | IgG FITC Conjugate |
| 00845714003462 | Coverslips |
| 00845714003448 | Mouse Kidney Slide |
| 00845714003387 | pANCA Slide |
| 00845714003370 | c+p ANCA COMBI Slide |
| 00845714003363 | Hep-2/Mouse Kidney/Stomach Slide |
| 00845714003332 | Hep-2/Mouse Kidney Slide |
| 00845714003318 | Negative Control |
| 00845714003257 | Intercellular Positive |
| 00845714003240 | Crithidia Luciliae Slide |
| 00845714003233 | Hep-2 Cells Slide |
| 00845714003226 | Hep-2 Cells Slide |
| 00845714003223 | Hep-2 Cells Slide |
| 00845714003066 | IgA/IgG FITC Conjugate w/EB |
| 00845714003059 | IgA/IgG FITC Conjugate |
| 00845714003035 | IgA FITC Conjugate |
| 00845714003011 | IgG FITC Conjugate |
Trademark Results [IMMCO DIAGNOSTICS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMCO DIAGNOSTICS 85314467 4117553 Live/Registered |
IMMCO Diagnostics, Inc. 2011-05-06 |
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