DRAP REGISTERED MEDICAL DEVICE
Total Human IgE ELISA is registered with DRAP under number MDIR-0000435 as a Class B (low to moderate risk) medical device, imported. The listed holder is Sure Bio Diagnostics & Pharmaceutical. Its listed renewal date (13 Jun 2024) has passed, so ask the supplier for the renewal letter.
Screening result
MDIR-0000435 · the class is taken from DRAP's list for this number
DRAP registered Class B/C/D list, 28 Aug 2025
It may have been renewed after DRAP's last list. Ask the vendor for the renewal letter.
ELI-00084
| Device | Total Human IgE ELISA |
|---|---|
| Class | B |
| Listed holder | Sure Bio Diagnostics & Pharmaceutical |
| Holder address | EE -10 Defence View Phase 11, Near Iqra University Shaheed-e-Millat Express Way, Karachi. |
| Manufacturing site | M/s Diagnostic Automation / Cortez Diagnostics Inc. 21250 Califa St, Suite 102 and 116 Woodland Hills, CA 91367, USA |
| Issued | 14 Jun 2019 |
| Renewal date | 13 Jun 2024 |
| Licence | ELI-00084 |
Specifications
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Screened 6 Oct 2026, 17:05 (Pakistan time). A screening aid, not an official DRAP verification.
More devices from this holder
Other DRAP registrations and enlistments listed for the same company.
| MDIE-0002034 | Nunc CryoTub | Class A |
| MDIR-0009587 | Easy Diagnosis Free TriIodothyronine (FT3) Test Kit (Immunofluorescence Method) | Class B |
| MDIR-0009588 | Easy Diagnosis Free Thyroxine (FT4) Test Kit (Immunofluorescence Method) | Class B |
| MDIR-0009589 | Easy Diagnosis Total TriIodothyronine (T3) Test Kit (Immunofluorescence Method) | Class B |
| MDIR-0009590 | Easy Diagnosis Total Thyroxine (T4) Test Kit (Immunofluorescense Method) | Class B |
| MDIR-0009591 | Easy Diagnosis Thyroid Stimulation Hormone (TSH) Test Kit (Immunofluorescence Method) | Class B |
Similar devices from other companies
Same device type listed by other holders, useful when comparing suppliers.
| MDIR-0008758 | FSH (CLIA) (Follicle stimulating hormone) LH (CLIA) (Luteinizing Hormone) Total B HCG (CLIA) (Beta-Human Chorionic Gonadotropin) | Class B | Nextek Healthcare |
| MDIR-0001353 | HUMAN T3 (Total Triiodothyronine), ELISA [54010] | Class B | Popular International (Pvt) Ltd |
| MDIR-0001354 | HUMAN T4 (Total Thyroxine), ELISA [54020] | Class B | Popular International (Pvt) Ltd |
| MDIR-0001186 | Vidas HCG (Total Human Chorionic gonadotropin) | Class C | Global Marketing Services |
Corrections
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Source: DRAP's published provisional lists. A screening aid, not an official DRAP verification; confirm with DRAP and the supplier's original documents.