FDA.report

MONOBIND, INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
20207262020726MONOBIND, INC.1N2026-01-01100 N. POINTE DR. Lake Forest CA US 92630

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00816870020006NeoLumax CLIA Analyzer - IN010+1(949)951-2665info@monobind.com
00816870020013LuMatic CLIA Analyzer - IN008+1(949)951-2665info@monobind.com
00816870020044Immunoassay Plate Washer - IN002+1(949)951-2665info@monobind.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
340921188323995K980088T-UPTAKE MICROPLATE EIAKHQ1998-02-04
340921816463493K972720FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)CGJ1997-09-02
340921980605790K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISACFT1997-06-24
340921093075002K971835ANTI-THYROGLOBULIN (TG) MICROPLATE ELISADDC1997-07-03
340921537849253K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAJNL1997-07-03
340921755818542K971780THYROTROPIN(TSH) ELISAJLW1997-06-24
340922034771897K971779TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIACDP1997-06-16
340921350155530K971709TOTAL THROXINE MICROPLATE EIA(225-300)KLI1997-06-16
340921277806454K181017Free Testosterone AccuBind ELISA Test SystemCDZ2018-07-20
340921961161948K063437ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300JLW2008-04-04
340921532957056K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300KLI2003-08-22
340921734158528K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300CEC2002-04-05
340921061190694
340921077496648
340921522496094
340921806437956
340921004702437
340921010453505
340921039014198
340921059709911
340921062242713
340921077556248
340921104592688
340921106886344
340921137520576
340921145640502
340921156421919
340921190623172
340921199849683
340921229081896
340921258337635
340921280640218
340921293926960
340921346016116
340921352568137
340921353478842
340921377489585
340921396075322
340921397769729
340921436103076
340921437856817
340921442642539
340921464597133
340921496572495
340921529423017
340921531495272
340921533590686
340921560215214
340921618026682
340921632541219
340921653824878
340921658679433
340921668508446
340921701252142
340921726025842
340921731252752
340921736757869
340921751355261
340921753936370
340921757777667
340921762362609
340921794306674
340921807948426
340921824909293
340921829033457
340921838600304
340921871031113
340921913251924
340921933953169
340921952259385
340921976520275
340921993531013
340922012404375
340922040064411
340922042406038
340922050310362
340922066190714
340922066496993
340922071284361

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JLW22008-04-04
KLI22003-08-22
CDZ12018-07-20
CEC12002-04-05
KHQ11998-02-04
CGJ11997-09-02
JNL11997-07-03
DDC11997-07-03
CFT11997-06-24
CDP11997-06-16

PMN

GUDID

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