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Medical device registration holder

Nextek Healthcare

184 DRAP registrations and enlistments (118 Class B, 58 Class C, 8 Class D) · Screen a DRAP number · Device types · Companies

DRAP lists

All devices of Nextek Healthcare

DRAP no.DeviceClassStatus
MDIR-0006616Anti-HBc (CLIA) 130210023M, 130610023MDValid to Apr 2029
MDIR-0006615Anti-HBc IgM (CLIA) 130210014M, 130610014MDValid to Apr 2029
MDIR-0006617Anti-HBe (CLIA) 130210022M, 130610022MDValid to Apr 2029
MDIR-0006618Anti-HBs (CLIA) 130210010M, 130610010MDValid to Apr 2029
MDIR-0006619Anti-HCV (CLIA) 130210015M, 130610015MDValid to Apr 2029
MDIR-0006620HBeAg (CLIA) 130210011M, 130610011MDValid to Apr 2029
MDIR-0006621HBsAg (CLIA) 130210009M, 130610009MDValid to Apr 2029
MDIR-0006614HIV Ab/Ag Combi (CLIA) 130219008M, 130619008MDValid to Apr 2029
MDIR-0006598AFP (CLIA) 130201033M, 130601033MCValid to Apr 2029
MDIR-0007107Anti-GAD (CLIA)CValid to Sep 2029
MDIR-0006777BNP (CLIA) 130206516M, 130606516M [100 Test Kit 50 Test Kit]CValid to Apr 2029
MDIR-0006775C-Peptide (CLIA) 130255001M, 130655001M [100 Test Kit 50 Test Kit]CValid to Apr 2029
MDIR-0006599CA 125 (CLIA) 130201031M, 130601031MCValid to Apr 2029
MDIR-0007087CA 15-3 (CLIA)CValid to Sep 2029
MDIR-0007086CA 19-9 (CLIA)CValid to Sep 2029
MDIR-0007088CA 242 (CLIA)CValid to Sep 2029
MDIR-0007085CA 50 (CLIA)CValid to Sep 2029
MDIR-0007090CA 72-4 (CLIA)CValid to Sep 2029
MDIR-0006774CEA (CLIA) 130201032M, 130601032M [100 Test Kit 50 Test Kit]CValid to Apr 2029
MDIR-0006780CK-MB (CLIA) 130256001M, 130656001M [100 Test Kit 50 Test Kit]CValid to Apr 2029
MDIR-0007080CMV IgG (CLIA)CValid to Sep 2029
MDIR-0007081CMV IgM (CLIA)CValid to Sep 2029
MDIR-0006600CRP (CLIA) 130266002M, 130666002MCValid to Apr 2029
MDIR-0006601cTnI (CLIA) 130256002M, 130656002MCValid to Apr 2029
MDIR-0006602Cyclosporine (CLIA) 130257001M, 130657001MCValid to Apr 2029
MDIR-0007089CYFRA 21-1 (CLIA)CValid to Sep 2029
MDIR-0006603D-Dimer (CLIA) 130256008M, 130656008MCValid to Apr 2029
MDIR-0007108Dengue virus NS1 Antigen (CLIA)CValid to Sep 2029
MDIR-0006778Digoxin (CLIA) 130257002M, 130657002M [100 Test Kit 50 Test Kit]CValid to Apr 2029
MDIR-0007102EBV EA IgA (CLIA)CValid to Sep 2029
MDIR-0007100EBV VCA IgG (CLIA)CValid to Sep 2029
MDIR-0007101EBV VCA IgM (CLIA)CValid to Sep 2029
MDIR-0007112EZ POC AFPCValid to Sep 2029
MDIR-0007110EZ POC CRPCValid to Sep 2029
MDIR-0007111EZ POC NT-proBNPCValid to Sep 2029
MDIR-0006610f-PSA (CLIA) 1130201005M, 130601005MCValid to Apr 2029
MDIR-0007091H-FABP (CLIA)CValid to Sep 2029
MDIR-0007093HE4 (CLIA)CValid to Sep 2029
MDIR-0007094HER-2 (CLIA)CValid to Sep 2029
MDIR-0006781hs-cTnI (CLIA) 130256014M, 130656014M [100 Test Kit 50 Test Kit]CValid to Apr 2029
MDIR-0007083HSV-1 IgG (CLIA)CValid to Sep 2029
MDIR-0007098HSV-1/2 IgG (CLIA)CValid to Sep 2029
MDIR-0007099HSV-1/2 IgM (CLIA)CValid to Sep 2029
MDIR-0007097HSV-2 IgG (CLIA)CValid to Sep 2029
MDIR-0007096IAA (CLIA)CValid to Sep 2029
MDIR-0006776IL-6 (CLIA) 130216504M, 130616504M [100 Test Kit 50 Test Kit]CValid to Apr 2029
MDIR-0007104Immunoassay ControlsCValid to Sep 2029
MDIR-0006604Insulin (CLIA) 130255002M, 130655002MCValid to Apr 2029
MDIR-0007092LP-PLA2 (CLIA)CValid to Sep 2029
MDIR-0006779Myoglobin (CLIA) 130256003M, 130656003M [100 Test Kit 50 Test Kit]CValid to Apr 2029
MDIR-0007084NSE (CLIA)CValid to Sep 2029
MDIR-0006605NT-proBNP (CLIA) 130256004M, 130656004MCValid to Apr 2029
MDIR-0007095PAP (CLIA)CValid to Sep 2029
MDIR-0007109PAPP-A (CLIA)CValid to Sep 2029
MDIR-0006606PCT (CLIA) 130266001M, 130666001MCValid to Apr 2029
MDIR-0007106Pepsinogen II (CLIA)CValid to Sep 2029
MDIR-0006773PIVKA-II (CLIA) 130201029M, 130601029M [100 Test Kit 50 Test Kit]CValid to Apr 2029
MDIR-0006611Rubella IgG (CLIA) 130212003M, 130612003MCValid to Apr 2029
MDIR-0007082Rubella IgM (CLIA)CValid to Sep 2029
MDIR-0007103S100 (CLIA)CValid to Sep 2029
MDIR-0006607Syphilis (CLIA) 130269003M, 130669003MCValid to Apr 2029
MDIR-0006609Tacrolimus (CLIA) 130257003M, 130657003MCValid to Apr 2029
MDIR-0006608Total PSA (CLIA) 130201004M, 130601004MCValid to Apr 2029
MDIR-0006612Toxo IgG (CLIA) 130212001M, 130612001MCValid to Apr 2029
MDIR-0006613Toxo IgM (CLIA) 130212002M, 130612002MCValid to Apr 2029
MDIR-0007105Tumor Marker ControlCValid to Sep 2029
MDIR-0009675[TruCal Albumin U/CSF high 193009910037 -3x1mL]BValid to Jul 2030
MDIR-000875017a-OH Progesterone (CLIA) (17a-Hydroxyprogeste rone)BValid to Apr 2030
MDIR-0008752ACTH (CLIA) (17a-Hydroxyprogeste rone)BValid to Apr 2030
MDIR-0008613ALAT (GPT) FS (IFCC mod.) (Alanine Aminotransferase (glutamic pyruvic transaminase)BValid to Mar 2030
MDIR-0008751Albumin (CLIA) (Albumin)BValid to Apr 2030
MDIR-0008623Albumin FS (Albumin)BValid to Mar 2030
MDIR-0008643Albumin in Urine/CSF FS (Micro albumin)BValid to Mar 2030
MDIR-0009656Albumin Standard FS [102009910030-6x3m L]BValid to Jul 2030
MDIR-0008740Aldosterone (CLIA) (Aldosterone) Direct Renin (CLIA) (Renin IVD)BValid to Apr 2030
MDIR-0008624Alkaline phosphatase FS IFCC 37C (Alkaline phosphatase)BValid to Mar 2030
MDIR-0008625Alpha-Amylase CC FS (Alpha-Amylase)BValid to Mar 2030
MDIR-0008725AMA-M2 IgG (CLIA) (Autoimmune)BValid to Apr 2030
MDIR-0008730AMH (CLIA) (Anti-Mullerian hormone) SHBG (CLIA) (Anti-Mullerian hormone) Androstenedione (CLIA) (Anti-Mullerian hormone)BValid to Apr 2030
MDIR-0008753ANA Screen (CLIA) (C-Reactive Protein )BValid to Apr 2030
MDIR-0008746Anti-B2-Glycoprotein 1 IgG (CLIA) (B2-Glycoprotein) Anti-B2-Glycoprotein 1 IgM (CLIA) (B2-Glycoprotein)BValid to Apr 2030
MDIR-0008754Anti-CCP (CLIA) (C-Reactive Protein)BValid to Apr 2030
MDIR-0008741Anti-Centromeres IgG (CLIA) (Centromeres) Anti-Histones IgG (CLIA) (Histones)BValid to Apr 2030
MDIR-0008742Anti-dsDNA IgG (CLIA) (Double-stranded DNA) ENA Screen (CLIA) (extractable nuclear antigens) Anti-Scl-70 IgG (CLIA)…BValid to Apr 2030
MDIR-0008729Anti-HAV (CLIA) (Hepatitis A Antibody) HAV IgM (CLIA) (Hepatitis A Antibody)BValid to Apr 2030
MDIR-0008743Anti-MPO IgG (CLIA) (Myeloperoxidase) Anti-Cardiolipin IgG (CLIA) (Cardiolipin) Anti-Cardiolipin IgM (CLIA) (Cardiolipin)BValid to Apr 2030
MDIR-0008744Anti-Rib-P IgG (CLIA) (Rib-P) Anti-Sm/RNP IgG (CLIA) (Sm/RNP) Anti-Sm IgG (CLIA) (Sm)BValid to Apr 2030
MDIR-0008745Anti-SS-A/Ro IgG (CLIA) (SS-A/Ro) Anti-SS-B IgG (CLIA) (SS-B) Anti-Jo-1 IgG (CLIA) (Jo-1)BValid to Apr 2030
MDIR-0008731Anti-Tg (CLIA) (Thyroid Antithyroglobulin Antibody) Thyroglobulin (CLIA) (Thyroglobulin) Anti-TPO (CLIA) (Anti-thyroid peroxidase)BValid to Apr 2030
MDIR-0008728Anti-TM (CLIA) (Anti-TM)BValid to Apr 2030
MDIR-0008614ASAT (GOT) FS (IFCC mod.) ((Aspartate Aminotransferase (glutamic oxaloacetic transaminase)BValid to Mar 2030
MDIR-0008634Beta-Hydroxybutyrate 21 FS (Beta-Hydroxybutyrate )BValid to Mar 2030
MDIR-0008628Bicarbonate FS (Bicarbonate)BValid to Mar 2030
MDIR-0009657Bicarbonate Standard FS [109509910030-6x3m L]BValid to Jul 2030
MDIR-0008629Calcium AS FS (Calcium)BValid to Mar 2030
MDIR-0009658Calcium Standard FS [111009910030 -6x3mL]BValid to Jul 2030
MDIR-0009659Cholesterol Standard FS [113009910030 -6x3mLBValid to Jul 2030
MDIR-0008650Cleaner A, Cleaner B, Cleaner response 920 (Cleaner)BValid to Mar 2030
MDIR-0008636Complement C3c FS (Complement Component 3)BValid to Mar 2030
MDIR-0008644Complement C4 FS (Complement component C4)BValid to Mar 2030
MDIR-0008755Cortisol (CLIA) (Cortisol)BValid to Apr 2030
MDIR-0009660Creatinine Standard FS [117009910030 - 6x3Ml]BValid to Jul 2030
MDIR-0008648Cystatin C FS (Cystatin C)BValid to Mar 2030
MDIR-0008747EPO (CLIA) (Erythropoietin)BValid to Apr 2030
MDIR-0008627Ethanol FS (Ethanol)BValid to Mar 2030
MDIR-0008732FA (CLIA) (Folic Acid) Vitamin B12 (CLIA) (Folic Acid)BValid to Apr 2030
MDIR-0008756Ferritin (CLIA) (Ferritin)BValid to Apr 2030
MDIR-0008647Ferritin FS (Ferritin)BValid to Mar 2030
MDIR-0008640Ferritin SR (Ferritin)BValid to Mar 2030
MDIR-0008757Free T3 (CLIA) (Triiodothyronine) Free T4 (CLIA) (Thyroxine)BValid to Apr 2030
MDIR-0008765Free Testosterone (CLIA) (Free-Testosterone)BValid to Apr 2030
MDIR-0008758FSH (CLIA) (Follicle stimulating hormone) LH (CLIA) (Luteinizing Hormone) Total B HCG (CLIA) (Beta-Human…BValid to Apr 2030
MDIR-0008631Gamma-GT FS (Szasz mod./IFCC stand.) (Gamma-glutamyl transferase)BValid to Mar 2030
MDIR-0008727Gastrin-17 (CLIA) (Gastrin IVD)BValid to Apr 2030
MDIR-0008615GLDH FS DGKC (Glutamate dehydrogenase)BValid to Mar 2030
MDIR-0008630Glucose GOD FS (Glucose oxidase)BValid to Mar 2030
MDIR-0008616Glucose Hexokinase FS (Glucose Hexokinase)BValid to Mar 2030
MDIR-0009662Glucose Standard FS [125009910030 - 6x3mL] Glucose Standard FS [125009910030 - 6x3mL]BValid to Jul 2030
MDIR-0008733Growth Hormone (CLIA) (Cortisol)BValid to Apr 2030
MDIR-0008734H.pylori IgA (CLIA) (Anti-Helicobacter pylori immunoglobulin)BValid to Apr 2030
MDIR-0008617HbA1c net FS (Hemoglobin A1c)BValid to Mar 2030
MDIR-0008651HbA1c net Hemolyzing Solution (HbA1c net Hemolyzing Solution)BValid to Mar 2030
MDIR-0008641HDL Precipitant (High Density Lipoprotein Precipitant)BValid to Mar 2030
MDIR-0008652HDL-c direct FS (High Density Lipoprotein Cholesterol)BValid to Mar 2030
MDIR-0008632Homocysteine FS (Homocysteine)BValid to Mar 2030
MDIR-0008759IgE (CLIA) (Immunoglobulin E) IgM (CLIA) (Immunoglobulin M)BValid to Apr 2030
MDIR-0008762IGF-I (CLIA) (Insulin-like-growth factor 1) IGFBP-3 (CLIA) (IGFBP-3)BValid to Apr 2030
MDIR-0008760IgG (CLIA) (Total immunoglobulin G) IgA (CLIA) (Total immunoglobulin G)BValid to Apr 2030
MDIR-0008637Immunoglobulin A FS (Immunoglobulin A)BValid to Mar 2030
MDIR-0008639Immunoglobulin E FS (Immunoglobulin E)BValid to Mar 2030
MDIR-0009655Immunoglobulin G FS [172129910921-4x80 Test] [172129910930-4x20 mL/2x8mL] [172129910935-2x20 mL/1x8mL] [172129910964 -540 TestBValid to Jul 2030
MDIR-0008638Immunoglobulin M FS (Immunoglobulin M)BValid to Mar 2030
MDIR-0008735Intact PTH (CLIA) (Parathyroid Hormone) 25-OH Vitamin D (CLIA) (25-Hydroxyvitamin D)BValid to Apr 2030
MDIR-0009661Iron Standard FS [119009910030 - 6x3mL] Glucose Standard FS [125009910030 - 6x3mL]BValid to Jul 2030
MDIR-0008633ISE Urine Diluent response (Urine Diluent)BValid to Mar 2030
MDIR-0008653Lactate FS (Lactate)BValid to Mar 2030
MDIR-0008761Laminin (CLIA) (Laminin) Col IV (CLIA) (IV collagen) Hyaluronic Acid (CLIA) (Hyaluronic)BValid to Apr 2030
MDIR-0008654LDH 21 FS (Lactate dehydrogenase)BValid to Mar 2030
MDIR-0008655LDL-c direct FS (Low Density Lipoprotein Cholesterol)BValid to Mar 2030
MDIR-0008656Lipase DC FS (Lipase)BValid to Mar 2030
MDIR-0009645Magnesium Standard FS [146009910030] [6x3Ml]BValid to Jul 2030
MDIR-0008657Magnesium XL FS (Magnesium), Magnesium XL FS (Magnesium)BValid to Mar 2030
MDIR-0008642one HbA1c Hemolyzing Solution (Hemoglobin A1c Hemolyzing solution)BValid to Mar 2030
MDIR-0008645oneHbA1c FS (Hemoglobin A1c)BValid to Mar 2030
MDIR-0008748Osteocalcin (CLIA) (Osteocalcin) Total P1NP (CLIA) (P1NP) B-CTx (CLIA) (B-CTx)BValid to Apr 2030
MDIR-0008626Pancreatic amylase CC FS (Pancreatic amylase)BValid to Mar 2030
MDIR-0008658Phosphate FS (Phosphate)BValid to Mar 2030
MDIR-0009646Phosphate Standard FS [152109910030] [6x3mL]BValid to Jul 2030
MDIR-0009648Phospholipids Standard FS [157409910041] [3x1mL]BValid to Jul 2030
MDIR-0008749PIIIP NP (CLIA) (Procollagen N-terminal peptide) Cholylglycine (CLIA) (Cholylglycine)BValid to Apr 2030
MDIR-0008635Prealbumin FS (Prealbumin)BValid to Mar 2030
MDIR-0008763Proinsulin (CLIA) (Proinsulin) ICA (CLIA) ( antibody) Anti-IA2 (CLIA) (antigen 2 antibody)BValid to Apr 2030
MDIR-0008736Prolactin (CLIA) (Prolactin)BValid to Apr 2030
MDIR-0008646Rheumatoid factor FS (Rheumatoid factor)BValid to Mar 2030
MDIR-0008726Serum Amyloid A (CLIA) (Serum Amyloid A)BValid to Apr 2030
MDIR-0009653TBA (Total bile acid Calibrator) [122409910037] [3x1mL]BValid to Jul 2030
MDIR-0008738Testosterone (CLIA) (Testosterone) DHEA-S (CLIA) (Dehydroepiandroster one-sulfate)BValid to Apr 2030
MDIR-0008618Total bile acids 21 FS (Total bile acids)BValid to Mar 2030
MDIR-0008619Total protein FS (Total protein)BValid to Mar 2030
MDIR-0008737TRAb (CLIA) (Thyroid uptake) T-Uptake (CLIA) (Thyroid uptake) Rev T3 (CLIA) (Thyroid uptake)BValid to Apr 2030
MDIR-0008649Triglyceride FS Triglyceride FS 10 (Triglycerides)BValid to Mar 2030
MDIR-0009647Triglycerides Standard FS [157009910030] [6x3mL]BValid to Jul 2030
MDIR-0009674TruCal Albumin U/CSF [Albumin U/CSF calibrator 193009910059-5x1mLBValid to Jul 2030
MDIR-0009667TruCal ASO [170109910059BValid to Jul 2030
MDIR-0009666TruCal CRP [TruCal CRP 150 170009910036 -3x2mL, TruCal CRP high 170009910037 -3x2mL, TruCal CRP…BValid to Jul 2030
MDIR-0009672TruCal D-Dimer [172609910047] [1x1mL/2x2.5mL]BValid to Jul 2030
MDIR-0009651TruCal E Calibrator [193109910079] [4x3mL]BValid to Jul 2030
MDIR-0009669TruCal Ferritin [170509910058 - 4x1mL]BValid to Jul 2030
MDIR-0009671TruCal Ferritin SR [172409910059 - 5x1mL]BValid to Jul 2030
MDIR-0009654TruCal HbA1c Hemoglobin A1c liquid calibrator [133209910043 -4x0.25mL] Hemoglobin A1c net calibrator [133509910044 -2x0.3mL]BValid to Jul 2030
MDIR-0009665TruCal Homocysteine [134009910041 - 3x1mL]BValid to Jul 2030
MDIR-0009670TruCal IgE 172309910059 - 5x1mL]BValid to Jul 2030
MDIR-0009649TruCal Lipid [135709910045] [3x2Ml]BValid to Jul 2030
MDIR-0009673TruCal PCT [173109910082 -6x1mLBValid to Jul 2030
MDIR-0009650TruCal Protein Calibrator [592009910039] [5x1mL] Protein high Calibrator [592009910037] [3x1mL]BValid to Jul 2030
MDIR-0009668TruCal RF [170209910059 -5x1mL]BValid to Jul 2030
MDIR-0009652TruCal U (Calibrator) [591009910063, 20x3mL] [591009910064BValid to Jul 2030
MDIR-0008739TSH (CLIA) (Thyroid stimulating hormone) Total T3 (CLIA) (Triiodothyronine) Total T4 (CLIA) (Total Thyroxine)BValid to Apr 2030
MDIR-0008764Unconjugated Estriol (CLIA) (Unconjugated Estriol)BValid to Apr 2030
MDIR-0008620Urea FS (Urea)BValid to Mar 2030
MDIR-0009664Urea Standard FS [131009910030 - 6x3mL]BValid to Jul 2030
MDIR-0008621Uric acid FS TBHBA (Uric acid)BValid to Mar 2030
MDIR-0008622Uric acid FS TOOS (Uric acid)BValid to Mar 2030
MDIR-0009663Uric acid Standard FS [130009910030 - 6x3Ml]BValid to Jul 2030

Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.