| Primary Device ID | 08721264790002 | 
| NIH Device Record Key | 59187206-9ebe-49c9-82d1-f25073450a44 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Anti-HbF R-PE | 
| Version Model Number | IQP-578R | 
| Catalog Number | IQP-578R | 
| Company DUNS | 490578678 | 
| Company Name | IQ Products B.V. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| 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 | 
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | |
| Phone | +31505757000 | 
| orders@iqproducts.nl | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 08721264790002 [Primary] | 
| MVU | Reagents, Specific, Analyte | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-11-21 | 
| Device Publish Date | 2024-11-13 | 
| 08721264790002 - Anti-HbF R-PE | 2024-11-21The R-PE conjugated monoclonal antibody anti-Hemoglobin F (HbF), clone NaM16-2F4, reacts with the y-chain of the human fetal hemoglobin molecule in its intact form. | 
| 08721264790002 - Anti-HbF R-PE | 2024-11-21 The R-PE conjugated monoclonal antibody anti-Hemoglobin F (HbF), clone NaM16-2F4, reacts with the y-chain of the human fetal hem | 
| 08719327451007 - Anti-panHb APC | 2023-07-27 The APC conjugated monoclonal antibody anti-pan Hemoglobin (panHb) antibody recognizes the α-chain of human hemoglobin. | 
| 08717953022325 - CMV Brite™[Only 5 CMV control slides], CMV Antigenemia Test Kit | 2022-09-14 The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect im | 
| 08717953022349 - CMV Brite™, CMV antigenemia detection kit | 2022-09-14 The CMV Brite™ Kit is intended for the qualitative detection of Cytomegalovirus (CMV) lower matrix protein pp65 by indirect im |