FDA.reportPublic FDA data

simpli-COLLECT

Primary DI
00884999051409
Brand
simpli-COLLECT
Company
ABBOTT MOLECULAR INC.
Model
09N93-001
Catalog number
09N93-001
Device description
simpli-COLLECT Urine Collection Kit
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYASystem for detection of nucleic acid from non-viral microorganism(s) causing STIs using specimens collected at home

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYASystem For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At HomeMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243410000simpli-COLLECT STI TestAbbott Molecular2025-01-30QYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884999051400PackageGS124In Commercial Distribution
00884999051409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088499905140030884999051400
00884999051409008849990514098849990514090884999051409

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)553-7042customerservice@abbottmolecular.com

Regulatory Flags#

DUNS number
878263359
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
00884999051737RealTime09R20-00109R20-0012026-07-06
00884999051744Alinity m09R20-00209R20-0022026-07-06
00884999051287Alinity m09N15-03B09N15-03B2026-04-13
00884999051690simpli-COLLECT09R16-00109R16-0012026-04-13
00884999052062Alinity m09N61-03B09N61-03B2025-11-20
00884999047846Alinity m09N26-00109N26-0012020-04-29
00884999047853Alinity m09N26-00209N26-0022020-04-29
00884999047860Alinity m09N26-01009N26-0102020-04-29
00884999047426Alinity m09N26-01209N26-0122020-04-29
00884999047440Alinity m09N26-01409N26-0142020-04-29
00884999047464Alinity m09N26-01609N26-0162020-04-29
00884999047501Alinity m09N26-00409N26-0042020-04-29
00884999048096Alinity m09N26-01909N26-0192020-04-29
00884999048171Alinity m09N26-02009N26-0202020-04-29
00884999048034Alinity m08N53-00208N53-0022020-08-18
00884999031814m20009K15-019K15-012016-09-01
00884999049369Alinity m09N79-09509N79-0952025-06-27
00884999049376Alinity m09N79-08509N79-0852025-06-27
00884999049383Alinity m09N79-03A09N79-03A2025-06-27
00884999051348simpli-COLLECT09R02-00109R02-0012025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111410731Simple 2 Test (Simple 2 Swab Home Collection Kit (Vaginal)PRIVAPATH DIAGNOSTICS LIMITEDQYA2026-04-15
00810111410748Simple 2 test (Simple 2 Urine Home Collection Kit (Penile))PRIVAPATH DIAGNOSTICS LIMITEDQYA2025-07-07
00884999051348simpli-COLLECTABBOTT MOLECULAR INC.QYA2025-06-26
30884999051349simpli-COLLECTABBOTT MOLECULAR INC.QYA2025-06-26
30884999051400simpli-COLLECTABBOTT MOLECULAR INC.QYA2025-06-26
00850024881327LetsGetChecked Urine Sample Collection Kit (SM02)PRIVAPATH DIAGNOSTICS LIMITEDQYA2022-03-30