A collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a
| Company | Devices | Share |
|---|---|---|
| Privapath Diagnostics Limited | 23 | 33% |
| Cue Health Inc. | 22 | 31% |
| Rda Spot, Uab | 18 | 26% |
| Randox Laboratories Limited | 4 | 6% |
| Enable Biosciences Inc. | 1 | 1% |
| U.S. Biotek Laboratories Llc | 1 | 1% |
| Medzah Industries | 1 | 1% |
Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) | 75 |
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 2 |
| OIA | Neonatal Blood Collection Kit And Screening Form (Excludes H | 1 |
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | 1 |
Use these as the dimensions to specify in a tender line.
70 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Capillary blood collection kit IVD", from 7 companies. The largest labeler is Privapath Diagnostics Limited with 33% of records.
PQD (Blood Specimen Collection Convenience Kit (Excludes Hiv)), OIB (Blood And Urine Collection Kit (Excludes Hiv Testing)), OIA (Neonatal Blood Collection Kit And Screening Form (Excludes H), NNK (Container, Specimen Mailer And Storage, Non-Sterile)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.