FDA.reportPublic FDA data

Non-Invasive Prenatal Screening (NIPS) + Carrier Screening Collection Kit

Primary DI
00860009842236
Brand
Non-Invasive Prenatal Screening (NIPS) + Carrier Screening Collection Kit
Company
Labcorp Genetics Inc
Model
K-INV-N-CARRIER / 000
Catalog number
K-INV-N-CARRIER / 000
Published
2023-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009842236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009842236008600098422368600098422360860009842236

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, clinicalA collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119359774
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009842274Straight Needle Phlebotomy KitK-INV-PHLEBOTOMY-SN/0002025-02-13
00860009842281Butterfly Needle Phlebotomy KitK-INV-PHLEBOTOMY-BN/0002025-02-13
00860009842267RNA + Hereditary Cancer Blood Collection KitK-INV-RNA / 0002023-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111410038LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410052LetsGetChecked Blood Sample Collection Kit (HCV)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410182LetsGetChecked Blood Sample Collection Kit (MHTP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410199LetsGetChecked Blood and Saliva Sample Collection Kit (MHTPC)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410205LetsGetChecked Blood Sample Collection Kit (MHTP)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410250LetsGetChecked Blood Sample Collection Kit (ANMH2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410366LetsGetChecked Blood Sample Collection Kit (TRFNUS+)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410540LetsGetChecked Blood Sample Collection Kit (GLCS)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410557LetsGetChecked Blood Sample Collection Kit (LEAD)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410588LetsGetChecked Blood Sample Collection Kit (HPSP)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410649LetsGetChecked Blood Sample Collection Kit (OBIOMVA & OBIOMV)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410694LetsGetChecked Blood Sample Collection Kit (EWB1)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410700LetsGetChecked Blood Sample Collection Kit (EDB1)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410793LetsGetChecked Blood Sample Collection Kit (KDRN)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410816LetsGetChecked Blood Sample Collection Kit (CDST1)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00810111410908LetsGetChecked Blood and Saliva Sample Collection Kit (PCOS3)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850024881877LetsGetChecked Blood Sample Collection Kit (BIOM)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850024881884LetsGetChecked Blood Sample Collection Kit (BIOM4)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850024881952LetsGetChecked Blood Sample Collection Kit (GLCSLIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-08-07
00850038691172Tasso+ Standard KitTasso Inc.PQD2026-07-06
00850038691189Tasso Mini Standard KitTasso Inc.PQD2026-07-06
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220803BASELINE Venous Sample Collection kitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitRANDOX LABORATORIES LIMITEDPQD2026-05-22
00850024881860LetsGetChecked Blood Sample Collection Kit (BIOM2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2026-05-06
00810010895011Aero-MedAERO-MED, LLCPQD2026-05-04
00810010894991Aero-MedAERO-MED, LLCPQD2026-04-07
00810010895004Aero-MedAERO-MED, LLCPQD2026-04-07