FDA.reportPublic FDA data

simpli-COLLECT

Primary DI
30884999051400
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
OTC
false
Sterile
false
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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
878263359
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
00884999051409simpli-COLLECTABBOTT MOLECULAR INC.QYA2025-06-26
30884999051349simpli-COLLECTABBOTT MOLECULAR INC.QYA2025-06-26
00850024881327LetsGetChecked Urine Sample Collection Kit (SM02)PRIVAPATH DIAGNOSTICS LIMITEDQYA2022-03-30