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SCANTIBODIES LABORATORY, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20208082020808SCANTIBODIES LABORATORY, INC.1N2026-01-019336 ABRAHAM WAY SANTEE CA US 92071
30266649263026664926SCANTIBODIES LABORATORY INC.1Y2026-01-018005 Saint Andrews Ave San Diego CA US 92154

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
341061596053605K954247SYSCON CONTROL ASSAYED & UNASSAYEDJJY1996-02-14
341061547935982K944788INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)CEW1995-07-19
341061928258423K060578CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)JKR2006-08-30
341061643808008K051888TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013CEW2005-10-18
341061933775523K051810WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014CEW2005-09-09
341061300557151K050748ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011CKG2005-05-20
3153462024692193K030258FIRST RESPONSE PREGNANCY TESTLCX2003-02-25
341061195517609K021032ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100CKG2002-06-03
341061012059034K004038TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600CEW2001-04-30
341061196245486
3153461196245486
341061223096295
3153461297719973
3153461534242677
341061574525547
3153461574525547
3153461581782265
3153461800819047
3153461832082106
341061837244601
3153461967132643
341061991098113
341061991482472
3153462068945051

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CEW42005-10-18
CKG42005-05-20
JKR12006-08-30
LCX12003-02-25
JJY11996-02-14

PMN#

GUDID#