FDA.reportPublic FDA data

RealTime

Primary DI
00884999031128
Brand
RealTime
Company
ABBOTT MOLECULAR INC.
Model
8L07-80
Catalog number
8L07-80
Device description
Abbott RealTime CT/NG Control Kit
Published
2016-09-01
Public version status
Update
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
LIODEVICE, SPECIMEN COLLECTION
LSLDNA-REAGENTS, NEISSERIA
MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIODevice, Specimen CollectionMicrobiology1
LSLDna-Reagents, NeisseriaMicrobiology2
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140354000ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NGAbbott Molecular, Inc.2014-05-09LSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884999031128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884999031128008849990311288849990311280884999031128

GMDN Terms#

Term, Definition table
TermDefinition
Multiple sexually transmitted pathogen nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0-10 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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884999051409simpli-COLLECT09N93-00109N93-0012025-06-26
30884999051349simpli-COLLECT09R02-00109R02-0012025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999051690simpli-COLLECTABBOTT MOLECULAR INC.LIO2026-04-13
00875197007251cobas® liat CT, NG and MG control kitRoche Molecular Systems, Inc.LSL2026-02-24
00875197007268cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.LSL2026-02-24
00875197007275cobas® liat CT/NGRoche Molecular Systems, Inc.LSL2026-02-24
38053326011826BD FCTCOPAN ITALIA SPALIO2026-01-26
38053326009557Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011710UriSponge™COPAN ITALIA SPALIO2025-03-12
00840165400303Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400327Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400341Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400075Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
00840165400105Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
00840165400129Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
00840165400143Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
00840165400167Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
00840165400181Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
00840165400204Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-19
50192253050910OEM CUSTOMER SPECIFICCardinal Health 200, LLCLIO2025-01-28
38053326011598UTM®COPAN ITALIA SPALIO2024-11-13
38053326011604UTM® COPAN ITALIA SPALIO2024-11-13
38053326011611UTM® COPAN ITALIA SPALIO2024-11-13
00862242000367EndosacTMAPEX MEDICAL TECHNOLOGIES, INC.LIO2024-09-05
07898996204631Viral Transport Media (VTM) 3mlA. L. B. LUZLIO2024-07-23
00810044208122Caplugs/EvergreenCAPlugsLIO2024-05-31