Trinity Biotech
Hemoglobin A1c assay, Premier Hb9210 HbA1c Analytical Column (2500)
3manufacturers in China registered for this device type
36catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Biohermes BIO & Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 3 |
| Shanghai Medconn Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Shanghai Medconn Biotechnology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 2 |
Record
| Listed by | Primus Corp., United States |
|---|---|
| FDA product code | LCP |
| Device type | Assay, Glycosylated Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.7470 |
| 510(k) | K891235 |
| Record published | 2016-09-06 |
| Record revised | 2024-12-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 2 to 28 °C |
| Sizes | Total volume 940 ml; total volume 3.8 l |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Premier Affinity A1c 500 – 1 kit | In distribution | |
| Ultra2 Affinity A1c 3000 | In distribution | |
| Premier Diluent Reagent – 3.8L | Total Volume 3.8 l | In distribution |
| Premier Hb9210 HbA1c Analytical Column (2500) | In distribution | |
| PDQ 2 Reagent – 940mL | Total Volume 940 ml | In distribution |
| Ultra2 Affinity HbA1c Analyzer (220V) | In distribution | |
| Premier Buffer A Reagent – 3.8L | Total Volume 3.8 l | In distribution |
| System Wash Reagent – 940mL | Total Volume 940 ml | In distribution |
| Premier Buffer A Plus Reagent – 3.8 L | In distribution | |
| PDQ Wash Reagent | Total Volume 940 ml | In distribution |
| Tri-stat Reagent Kit | In distribution | |
| 2 Diluent Reagent – 940mL | Total Volume 940 ml | In distribution |
| 2 Diluent Reagent – 3.8L | Total Volume 3.8 l | In distribution |
| Premier Affinity A1c 1000 – 1 kit | In distribution | |
| Ultra2 Buffer B Reagent – 940mL | Total Volume 940 ml | In distribution |
| Premier Hb9210 HbA1c Analyzer – 1 each | In distribution | |
| Premier Buffer A Reagent – 940mL | Total Volume 940 ml | In distribution |
| Ultra2 Buffer B Reagent – 3.8L | Total Volume 3.8 l | In distribution |
| Premier Wash Reagent – 940mL | Total Volume 940 ml | In distribution |
| Premier Buffer B Reagent – 940mL | Total Volume 940 ml | In distribution |
| PDQ1 Reagent – 940mL | Total Volume 940 ml | In distribution |
| Ultra2 Affinity HbA1c Analyzer (110V) | In distribution | |
| PDQ Diluent Reagent – 940mL | Total Volume 940 ml | In distribution |
| Premier Hb9210 HbA1c Analytical Column (500) | In distribution | |
| Ultra2 Buffer 2A Reagent – 940mL | Total Volume 940 ml | In distribution |
| Tri-stat 2 Analyzer | In distribution | |
| Premier Buffer B Reagent – 3.8L | Total Volume 3.8 l | In distribution |
| Ultra2 Buffer 2A Reagent – 3.8L | Total Volume 3.8 l | In distribution |
| Premier Hb9210 HbA1c Analytical Column (4000) | In distribution | |
| Premier Affinity A1c 3000 – 1 kit | In distribution | |
| Affinity Analytical Column | In distribution | |
| Premier Sample Diluent Reagent – 940mL | Total Volume 940 ml | In distribution |
| Premier Hb9210 HbA1c Analytical Column (1500) | In distribution | |
| Premier Hb9210 HbA1c Analytical Column (1000) | In distribution | |
| Premier Buffer A Plus Reagent – 940 mL | In distribution | |
| Enzyme Cleaner Tube | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Variant II Turbo | Bio-Rad Laboratories Inc. | 15 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 11 |
| Variant II Turbo Link | Bio-Rad Laboratories Inc. | 7 |
| D-10 | Bio-Rad Laboratories Inc. | 7 |
| Variant II Hemoglobin A1c | Bio-Rad Laboratories Inc. | 5 |
| Drew Scientific | Drew Scientific, Ltd. | 5 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Corp. | 4 |
| D-100 | Bio-Rad Laboratories Inc. | 4 |
| Fructosamine | Roche Diagnostics Gmbh | 4 |
| D-10 Dual | Bio-Rad Laboratories Inc. | 3 |
| JAS Diagnostics | Drew Scientific, Ltd. | 3 |
| Henry Schein | Henry Schein, Inc. | 2 |
Showing 12 of 134. All products under Assay, Glycosylated Hemoglobin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062658 | 2007-11-26 |
| K993131 | 2000-05-22 |
| K994045 | 1999-12-21 |
| K992921 | 1999-11-12 |
| K942009 | 1994-09-14 |
| K936204 | 1994-03-22 |
| K940143 | 1994-03-15 |
| K896582 | 1990-06-28 |
| K891235 | 1989-06-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.