FDA.reportPublic FDA data

KidneyIntelX Blood Collection Convenience Kit

Primary DI
00196852040506
Brand
KidneyIntelX Blood Collection Convenience Kit
Company
Renalytix Ai, Inc.
Model
RENX-3011000
Device description
Collection convenience kit used to collect, contain and ship human blood to a Renalytix clinical laboratory for KidneyIntelX testing.
Published
2022-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
00196852040506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196852040506001968520405061968520405060196852040506

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kitA collection of 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 laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius36 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-203-2725ClientServices@renalytix.com

Regulatory Flags#

DUNS number
117063935
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009877924kidneyintelX.dkd Test12024-09-30
00860009877931kidneyintelX.dkd Single Tube Specimen Collection KItRENX-30110872024-04-16
00860009877917RenalytixAI Urine Collection KitRENX30110032022-05-06
00860009877900KidneyIntelX Blood Collection Convenience KitRENX-30110002022-03-25
00196852375677RenalytixAI Urine Collection KitRENX30110032022-05-06
G229RENX30110031RenalytixAI Urine Collection KitRENX30110032022-05-06
G229RENX30110001KidneyIntelX Blood Collection Convenience KitRENX-3011000RENX-301100022022-03-25
G229RENX301100021KidneyIntelX Blood Collection Convenience KitRENX-30110002RENX-301100022022-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10885380211225Aero-MedAERO-MED, LLCPQD2026-03-20
50885380211223Aero-MedAERO-MED, LLCPQD2026-03-20
00850070635158KIT, BLOOD CULTURE COLLECTINGNar Medical Depot, LLCPQD2026-03-19
00810010894885Aero-MedAERO-MED, LLCPQD2026-03-17
50810010894880Aero-MedAERO-MED, LLCPQD2026-03-17
00810010894960Aero-MedAERO-MED, LLCPQD2026-03-17
00850066710272Simple HealthKitSIMPLE HEALTHKIT, INC.PQD2026-01-21
04779054721198RDA SpotRDA SPOT, UABPQD2026-01-15
00850015884351easycareSynchronis Medical, LLCPQD2026-01-07
00850015884368easycareSynchronis Medical, LLCPQD2026-01-07
04779054721129RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721143RDA SpotRDA SPOT, UABPQD2025-11-20
04779054721082BLOODORDA SPOT, UABPQD2025-10-16
04779054721105BLOODORDA SPOT, UABPQD2025-10-16
04779054721112BLOODORDA SPOT, UABPQD2025-10-16
04779054721099BLOODORDA SPOT, UABPQD2025-10-13
04779054720276ZinzinoRDA SPOT, UABPQD2025-10-03
04779054720184ZinzinoRDA SPOT, UABPQD2025-09-16
04779054721013ZinzinoRDA SPOT, UABPQD2025-07-24
00810111410045LetsGetChecked Blood Sample Collection Kit (LIPP2)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07
00810111410281LetsGetChecked Blood Sample Collection Kit (PRGS)PRIVAPATH DIAGNOSTICS LIMITEDPQD2025-07-07