Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Helena Laboratories and its 1 subsidiaries with 283 510(k) clearances and 16 device recalls. The most recent is a 510(k) clearance dated Oct 13, 2022: SPIFE A1AT kit.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Helena Laboratories and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 13, 2022 | SPIFE A1AT kitK213396 · OBZ | 510(k) clearances |
| Apr 19, 2022 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlK192931 · GKA | 510(k) clearances |
| Apr 4, 2017 | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma CoClass II · Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Soluti | Device recalls |
| Feb 24, 2017 | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT OClass II · Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in | Device recalls |
| Nov 7, 2016 | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTClass III · Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enz | Device recalls |
| Oct 14, 2016 | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mLClass II · Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay rang | Device recalls |
| Apr 20, 2016 | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT OClass II · Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times | Device recalls |
| Oct 7, 2013 | V8 SP NORMAL CONTROL, ABNORMAL CONTROLK131479 · JJY | 510(k) clearances |
| Jun 26, 2012 | THE HELENA V8 IMMUNODISPLACEMENT KITK111369 · CFF | 510(k) clearances |
| Dec 15, 2010 | SPECIALTY ASSAYED CONTROL-2K100103 · GGC | 510(k) clearances |
| Feb 23, 2007 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061991 · GHR | 510(k) clearances |
| Jul 6, 2006 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061069 · CFF | 510(k) clearances |
| May 10, 2006 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK061014 · JPA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
